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Specializing in Pharmaceutical Technologies

Data Entry|Programador | Diseño Gráfico | SEO Servicios para su empresa

¿Usted está luchando trabajar con independientes desarrolladores / diseñadores y en busca de una solución fiable aún rentable. Dejamos que usted emplea empleados virtuales contractuales para cualquier servicio relacionado TI (computación), como software / web / aplicación móvil / diseño gráfico o la entrada de datos en tiempo completo / tiempo parcial / base de proyecto.

Disponibilidad- actual de recursos

1- Diseñador Gráfico – EXP 2-5 Años – ($ 749- $ 1499) [disponibilidad-2]

2- Diseñador HTML -Exp- 3 Years- $ 1349 [disponibilidad-2]

3- PHP o la red del punto Developer- EXP 1-3 Años – ($ 999- $ 1999 [disponibilidad-4]

4- Mobile App Developer: $ 1500 [disponibilidad-2]

5- Contenido escritor-$ 999 [disponibilidad-3]

6- SEO / pago por clic de Google experto- $ 999 [disponibilidad-4] Entrada de Datos

7- (búsqueda de datos, Gestión de la lista, CMS entradas- $ 799 También disponible, Desarrolladores/programadores con mas experiencia (MS SQL o Oracle, .NET, PL/SQL), administradores de proyectos para diversas tecnologías! Las principales características son: • contrato de mes a mes • escalar fácilmente y rápidamente hacia arriba / abajo

Responder a este correo electrónico con sus requisitos / consultas y estaré feliz de compartir nuestro perfil de empresa or Click aqui!

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Social Media Management – administramos tu redes sociales @ raeclinica.eu

Website Design & Development-Diseño de pagina web para abogados, sociedades y todo tipo de compañias.

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Website Design & Development for your business in Panama.

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Diseno Web, Redes Sociales, Paginas Web

Visite www.iiocreativesolutions.com para mas información. Servicio en Panamá.

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Case Study 4: A Full Data Management Solution

Working in a Collaborative Environment

The Scenario:

A phase II study was being managed by a CRO that had non-dedicated teams, escalating costs, with project timelines slipping on almost every deliverable.
RA eClinica Solution:

    • RA eClinica assumed responsibility for entire data management activities consisting of Data Management, Study Build / EDC Development, and Statistics and Programming.
    • RA eClinica preferred Data Management systems utilized with Sponsor’s Safety Surveillance system and Clinical Trial Management System, CTMS

Ra eClinica Results:

    • Study ongoing – All deadlines to date have been met or exceeded
    • Cost savings of approximately 35% in comparison to traditional CRO models
    • No turnover since study start

Anayansi Gamboa- Virtual DM Service from RA eClinica

RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.

The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union. For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.

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Case Study 3: Out-of-Box Solution

The Scenario:

The Sponsor required a solution to effectively manage and control users (internal and external).
RA eClinica Solution:

    • RA eClinica collaborated with the Sponsor to develop and implement a user management system that involved training tracking record (LMS), user access request, Role-based access control
    • Develop, deploy and host the clinical documentation service and provide customer support.

Ra eClinica Results:

    • Development of an electronic tool to manage the program and provide ongoing operational management support..
    • Reports are made accessible based on permission on a web browser CFR-Part 11 compliance is maintained on security and privacy of data.
    • Reports are XML-tagged for further integration with in-house systems and third party service providers,
    • Integrated Help desk support system

Anayansi gamboa - Out of the box solutions by RA eClinica

RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.

For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.

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Case Study 2: Supporting the Sponsor with Database Transfer Solution

Assisting the Sponsor with Database Transfer Solution

Anayansi gamboa - Data Management Support @RAeClinica

 

 

 
The Scenario:

The Sponsor required a large safety and data management team to assist for a submission deadline requiring the transfer of data to a new safety database for clinical trials and post-marketed products.
RA eClinica Solution:

    • RA eClinica responsible for AE/SAE reporting, safety coding, NDA submission support
    • RA eClinica collaborated with the Sponsor’s safety team to develop a functional safety alliance consisting of over 10+ team members inclusive of management, safety and data management resources
    • Ra eClinica team is responsible for managing over 5+ compounds

Ra eClinica Results:

    • RA eClinica project team exceeded the timelines, completing the tasks approximately 30-days ahead of schedule
    • RA eClinica management collaborate with the Sponsor to redefine operational workflow and processes in order to increase efficiencies across several departments (Quality Control, Pharmacovigilance)

RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.

The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union. For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.

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Case Study 1: Stand Alone Satellite Office Solution

Integrated Into Sponsor’s Clinical Data Management (CDM) Environment

Anayansi gamboa - offshore Panama Data management

 

 

 

 

The Scenario:

The Sponsor was in need of a data management team to function in an integrated manner as an extension of the Sponsor’s CDM team. Based on geographic and offices constraints, coupled with the large volume of work, hiring individual contract resources on-site was not an option.

RA eClinica Solution:

  • RA eClinica Data Management Operations collaborated with Sponsor to develop CDM metrics, collaboration model and workflow, enabling the team to work across 3+ protocols
  • RA eClinica provided a full solution of 5+ CDM resources, project management, dedicated secure facilities integrating into Sponsor’s eClinical and CDMS databases.

Ra eClinica Results:

  • Develop of a long-term, efficient and cost-effective CDM solution.

RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.

The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union. For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.

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Contract for Consultants/Freelancers: Part I

As a consultant/freelancer, you have to deal with contracts. In the last few years, I have come to the realization that there is no such things as LAW. CONTRACT Law is the only law. So forget about what you think you know (e.g. bill of rights, constitutions, or State or local laws). It doesn’t exists. Those are codes or regulations. Statutes and not real law. It only applies to legal persons. Are you a legal person (corporation)? Read on…

Remember, anything that requires your signature, or a swearing thereto in order to give it application, is not law, but a contract.– Ron Branson (J.A.I.L. – Judicial Accountability Initiative Law)

If there is no contract there is no case. Contract is the law.

All CONTRACTS in order to be valid, must be signed by someone able to bind the corporation in contract. So next time you receive a piece of paper in the mail, know that they (i.e. corporations) are trying to contract with you.

If you simply tell them you don’t want to contract with them where is the controversy? What is there to judge? The only reason any matter ever goes to court is because the officers of the court know that at some point you will unwittingly grant them JURISDICTION over you. Until you do this, they cannot hold you –no matter what you think you might have done.

This brings me to my first (1st) point when you get a contract from a recruiter, agency or corporation: make sure the JURISDICTION is your JURISDICTION. This is sometimes difficult as you are at the mercy of the corporation offering you the job or contract. Hence, 9 out of 10 times, you will have two choices: decline the offer or negotiate the contract. If they know you are the only best candidate for the contract/assignment, then most likely they will negotiate with you and accommodate your requirements. Otherwise, walk-away. You will avoid headaches and contract disputes in the future.

Remember that no recruiter can bind their corporation in contract. They probably have a legal department or lawyer working on their behalf. So make sure you know how to read those contracts. By the way, the language used in most contract is called ‘legalese’. It is not English or Spanish or Hindu. It is legalese.

Anayansi Gamboa - Signatures on Contract
Detail view of the signature box of a contract with a pen.
 All Law is Contract; Every Interchange Between People is Contract; All Commerce is Contract; Contract Makes the Law

Now I will leave you with an excerpt from the book: HOW I CLOBBERED EVERY BUREAUCRATIC CASH-CONFISCATORY AGENCY KNOWN TO MAN – Mary Elizabeth: Croft

At common law, these eight elements are essential to the creation of a contract: offer, acceptance, intention, sufficient and equal consideration, mental and lawful capacity to contract, legality of purpose, genuine consent (knowingly, willingly, and voluntarily), certainty of terms and conditions.

You are usually tricked into contracting. I heard of a woman who was charged with writing ‘bad cheques’ and prior to sentencing was asked by the judge if she had anything to say. This is called, ‘allocution’ and is the time for the ‘defendant’ to say what’s so. Unfortunately, most defendants fail to take advantage of this opportunity to set the record straight. She, however, told the judge, “With all due respect, I do not accept your sentence.” The judge then said, “I sentence you to 25 years.” Again she said, “I do not accept your sentence.” He called both attorneys, who were now visibly irate, to come forward. The judge then asked, “Well, Ms. … , would you think it kind of the court to sentence you to only 10 years?” Again she said she would not accept his sentence. The judge’s final words, to the dismay of the attorneys, were, “I hereby dismiss this case and all charges are dropped.” He couldn’t do anything without her agreement. This is the power of contracts.

By the way, it is impossible to write a ‘bad cheque’; there is no such thing. If it has a date, a payee, a $$$ amount, and an autograph it is a lawful commercial instrument because the funds are created by those four requirements. If it is kept by the corporate entity to which one has specified ‘credit/pay to the order of’, then it is clearly being used as such. Don’t let anyone tell you that you wrote a ‘bad cheque’. Sure, there might not have been debt funds in the account to cover it yet that doesn’t mean that the private side hasn’t been accessed. In fact, you can be certain that it has been if it weren’t returned to you and if it has been returned then keep in mind that a debt/ legal tender (payment) offered in honour (in good faith) and refused, is a debt discharged. There is no commercial crime here except on the part of the entity trying to charge you with ‘writing a bad cheque.’

Remember: A Promissory Note is a Promissory Note is a Promissory Note…….more later when I recount my latest adventures with RBC (Royal Bank of Canada) and CRA (which continues to change its name – so just remember it as the Canadian version of IRS).

An offer of contract becomes binding after 72 hours (3 days); after seven (7) days there is a default and after ten (10) days there is a summary judgement. So handle your offers immediately.

The basis of 99% of all legal actions is derived from a ‘person’ (strawman) being sued, or accused of having entered into and breached a commercial contract, or being presumed to have entered into and breached a commercial contract. If the contract does not meet the four legal requirements, it is void. In order to live free we must remain eternally vigilant of these invisible contracts and avoid the presumption of their existence.

The most significant presumptions are:
1. that you are a resident;
2. that you depend upon the government for benefits;
3. that you are not responsible for your behavior; and
4. that you need protection – an attorney, a financial advisor, a doctor, a fiat currency, etc.
(Protect me from the protectors.)

All the above are false presumptions the existence of which is perpetuated upon the belief that all land and people are collateral for a debt which supports a fraudulent monetary system. All are based upon the presumption that certificates of ‘birth’/ ‘title’, etc., in commercial law, waive our right to take responsibility for our own affairs and own our bodies, plus life, liberty, and the property we accumulate through trading our labour with others or creating from raw materials, if we don’t object to or arrange our affairs otherwise.

The PTB, FED (Federal Reserves private bank), IMF (International monetary funds), ECB (European Central Banks) have established a long history (hundreds of years) of lending what is considered ‘money’ or ‘credit’ and then calling in debts, and creating wars around the world over these debts.

On Part II, I will cover what ‘legalese’ language you should look for (‘red flags’) and how to make it work for you. And one more thing, avoid recruiters from the UK or London areas. Most of them are not even registered in the country they represent (e.g. Germany or Belgium). Avoid umbrellas companies too. For European contracts, registered yourself as business and handle your affairs directly, if possible. For USA/North American contracts, you do not need to be registered as corporation (not yet though, things are changing rapidly in this part of the world). Just make sure you look for the legalese keywords. More on this on my next article.

No Disclaimer: There is no disclaimer in this article because the reader will learn that we are all responsible for our perception and interpretation of anything and everything we experience. I have no intention of disclaiming anything I write. – Anayansi Gamboa, DBA GAMBOA

Images: Copyright images from Google images

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HTML Tips to Enhance Your eCRF

In some cases, the display of your OpenClinica eCRF may not be exactly what you had in mind. You may want to highlight key words or phrases, create a bullet point list, or insert a URL or image. Using HTML tags, you can make some simple manipulations to change the look and feel of your case report forms and make them more inviting for data entry.

Using HTML tags to enhance your eCRF

The HTML tags described in this document can be used in the following columns in the CRF Excel template:

  • Items Tab: LEFT_ITEM_TEXT
  • Items Tab: RIGHT_ITEM_TEXT
  • Items Tab: HEADER
  • Items Tab: SUBHEADER
  • Sections Tab: INSTRUCTIONS

What are HTML tags?

HTML, or Hyper Text Markup Language, is a markup language that is commonly used for web page development. HTML is written using “tags” that surround text or elements. These tags typically come in pairs, with a start tag and an end tag:

<start tag>Text to format</end tag>

To insert an HTML tag, simply surround the text you want to format with the desired tag. Below are the HTML tags that work in OpenClinica:

Table

You can download this HTML Tags Knowledge Article to help you to get started.

Inserting URLs and Images

HTML also allows you to insert a URL or Image into your CRF, which may be used to provide users with additional information or references.

Insert a URL

A URL may be inserted into a CRF in order to provide a link to further instructions or protocol information. To insert a URL into your CRF, use the following format:

Inserting images - using HTML tags to optimize your eCRF

Simply replace the areas highlighted in yellow with (a) your URL (inside the quotation marks) and (b) the hyperlinked text that you want to display to the user.

The following example will prompt the user to “Click Here!” and will open the OpenClinica website in a new browser tab:

<a href=”https://www.openclinica.com&#8221; target=”_blank”>Click Here!</a>

Inserting an image - using HTML tags to optimize your eCRF

Insert an Image

Similarly, HTML can be used to insert an image into your CRF. You might consider using an image to display a pain scale (or other reference image), or even to display your company’s logo.

Inserting an image - using HTML tags in OpenClinica

To insert an image into your CRF, use the following format:

<img src=”images/ImageName”>

Again, simply replace the highlighted text with your image name. You can use PNG, JPG, or GIF image extensions. You can control the height and width of the image using the following format:

<img src=”images/ImageName” width=“n” height=“n”>

The highlighted n corresponds to the desired width and height of the image in pixels.

The following example will insert an image (image1.png) with a width of 300 and a height of 150:

<img src=”images/image1.png” width=”300″ height=”150″>

You can download this Images & URLs Example CRF to help you practice.

The examples included in the above CRF Excel template will insert an image that already exists in the images directory of your OpenClinica application. To insert a custom image, community users will need to place the image in the following directory of the OpenClinica application:

\tomcat\webapps\OpenClinica\images

OpenClinica Enterprise customers can request an image be placed on the application server by reaching out to the OpenClinica Enterprise Support team via the Issue Tracker.

Have you used HTML in your CRFs? Let us know if you have any other suggestions or tips!


IMPORTANT NOTES:

 The RESPONSE_OPTIONS_TEXT field is not included in the list above, as HTML tags are currently not supported for response options.

 The QUESTION_NUMBER field will display the text properly, but has been known to cause issues when extracting data. Therefore, HTML should not be used in this column.

 

Source: This article was posted by OpenClinica.

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eClinical Training

Training—Make the most of affordable, informative, educational events to polish your professional skills.

Electronic Data Capturing

Medidata Rave
Web-based Data Management System for the collection of clinical trials data.
Our consultants are available short- and long-term projects.
Credentials:
– Medidata Rave Certified
– 4+ years experience in study build
– Custom Functions / C# Developers
– Crystal Reports Developers / JReview Developers

InForm Architect / Central Designer / InForm EDC
Learn InForm at your own paced or via online

Data Management Training 101
For entry levels and those seeking to enter the clinical research industry.

One-on-One Training
Interested in learning RAVE / InForm / Oracle Clinical? Contact us for more details…

Upcoming Public Training:

Public Class is scheduled in Chennai: – Topic: Oracle Clinical / RDC study setup. Dates: 21-Oct-2015 to 29-oct-2015

You can download the agenda from the Website or use the link below: https://lnkd.in/eicR8fW For details please contact Life Sciences Expertise at info@LifeSciencesExpertise.com

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InForm EDC Features and Functionality

InForm 4.x Training
Learn the differences between 4.5 and 4.6 and new features

RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.

The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union.  For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.

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Solving Data Collection Challenges

Cross-partnership between sponsors and CROs for the collection and analysis of clinical trial data are complex. As a result there are a number of issues encountered during the running of  trial.

As with many projects, standardization projects like CDISC is a huge undertake. It requires resources, technology and knowledge-transfer. The industry (FDA for example) has been working on standardization for years but on September 2013, it became official, in which the FDA released a ‘Position Statement‘.

 Data Collection

According to the WHO, data collection is defined as the ongoing systematic collection, analysis, and interpretation of health data necessary for designing, implementing, and evaluating public health prevention programs.

Sources of data: primarily case report books or (e)CRF forms, laboratory data and patient report data or diaries.

 Challenges of data collection

It is important for the CROs / service providers to be aware of the potential challenges they may face when using different data collection methods for partnership clinical studies. Having several clients does not mean having several standards or naming conventions. This is the main reason why CDISC is here. So why are many CROs or service providers not using CDISC standards?

Another challenge is time limitations. Some clinical trials run for just a few weeks / months.

It may be found difficult to understand the partnership in the amount of time they have. Hence, most CROs and service providers prefer to perform manual mapping at the end of the trial, hence, re-work and manual work.

Funding also plays a key challenge for CDISC-compliance data collection study. Small researchers or biotechnology companies that do not have the resources in-house, out-sourced this task to CROs or service providers and are not interested whether it is compliance as long as it is save them money. But would it save money now instead of later in the close-out phase?

Anayansi Gamboa - Data Status

 

 

 

 

 

If there is a shortage of funding this may not allow the CRO or service provider all the opportunities that would assist them in capturing the information they need as per CDISC standards.

We really don’t have the level of expertise or the person dedicated to this that would bring, you know, the whole thing to fruition on the scale in which it’s envisioned – Researcher

Role of the Library

There is a clear need for libraries (GL) to move beyond passively providing technology to embrace the changes within the industry. The librarian functions as one of the most important of medical educators. This role is frequently unrecognized, and for that reason, too little attention is given to this role. There has been too little attention paid to the research role that should be played by the librarian. With the development of new methods of information storage and dissemination, it is imperative that the persons primarily responsible for this function should be actively engaged in research. We have little information at the present time as to the relative effectiveness of these various media. We need research in this area. Librarians should assume an active role in incorporating into their area of responsibility the various types of storage media. [http://www.ncbi.nlm.nih.gov/pmc/articles/PMC232677/]

Review and Revise

At the review and revise stage it might be useful for the CRO or service provider to consider what the main issues are when collecting and organizing the data on the study. Some of these issues include: ensuring sponsors, partners and key stakeholders were engaged in the scoping phase and defining its purpose; the objectives have been considered; the appropriate data collection methods have been used; the data has been verified through the use of multiple sources and that sponsors have approved the data that is used in the final clinical data report.

Current data management systems must be fundamentally improved so that they can meet the capacity demand for secure storage and transmission of research data. And while there can be no definitive tools and guideline, it is certain that we must start using CDISC-standards from the data collection step to avoid re-inventing the wheel each time a new sponsor or clinical researcher ask you to run their clinical trial.

RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.

The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union.  For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.

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Successful Interview – Get The Job That You Want

Lifetime entrepreneurs, consultants and freelancers have a real problem of working for someone else or working a 9-5 office environment. Who could you work for right now and be happy? But if you find yourself invited to attend an in-person interview, I have listed some suggestions for a successful interview.

Steps for a successful interview:

  1. Build Rapport — very obvious, but it warrants mentioning. First impressions mean so much, so be friendly and open. Be sure to shake hands with each person you are interviewing with and introduce you. You might also ask for a card at this point.

  2. Establish needs — This is as much the opportunity to learn about us as for us to learn about you. Establishing what we are specifically looking for will help you target your answers regarding your own qualifications. Asking questions also shows your interest. Have 3 questions prepared before the interview. You will want to have different questions for each person, if known in advance. This shows you’ve done your homework and reinforces your interest in the company. Have them memorized, but if you get stuck or nervous, you can refer back to these questions.

    Take the time to review the website:CLIENT WEBSITE: check the company’s website prior to the interview.

  1. Flesh out concerns — At the end of the interview, ask if there are any questions or concerns about your qualifications. Be direct about asking, “Do you have any concerns about my qualifications?” This gives you the opportunity to answer these questions or concerns on the spot.

  2. Ask for the job — At the end of the interview, let them know the level of your interest. Let them know you want the job. This lets the interviewer(s) know exactly where you stand. It also makes you stand out in his/her (the interviewer) mind.

  3. Restate your interest — best in the form of an emailed “Thank You.” The “Thank You” e-mail should be a brief email to the interviewer(s) to highlight the strengths you’ll bring to the position and restate your interest. I will expect a call after your interview, so you can provide a summary of your interview experience.

Don’t be shy about your qualifications. Be direct and be prepared.

  • Bring paper and a pen, as well as two (2) copies of your resume, one in case an interviewer needs one and the other for you to be able to reference for dates, etc. Be prepared, you might be meeting with multiple people, bring extra copies of your resume in case they need copies as well.

  • Don’t discuss the “What’s in it for me questions?” – in terms of salary, benefits, vacation. It is NOT appropriate to discuss these questions even if the interviewer opens this discussion topic. If the interviewer persists, please consider the following response: “the financial arrangement has already been discussed and confirmed between my agency and myself. I assure you that I am very interested in this opportunity.” or “I would prefer to discuss the salary requirements when an offer is made”.

Remember that when you go for a job interview, you are not asking them to pay you money. You are offering a PROFIT!

anayansigamboa-you are hired

Remember, it cost the company double to hire you (hiring, training, firing, benefits, etc). You are making the company money and providing value.

GOOD LUCK! and tell me about it in the comments!

Anayansi Gamboa specializes in Pharmaceutical Technologies and is available for short-term contracts or ad-hoc requests.

Disclaimer: The legal entity on this blog is registered as Doing Business As (DBA) – Trade Name – Fictitious Name – Assumed Name as “GAMBOA”.

I am someone who influence my own development. I look for a company where I have the opportunity to pursue my interests across functions and geographies, and where a job title is not considered the final definition of who I am, but the starting point.

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The Only Three (3) [Programming] Languages You Should Learn Right Now (eClinical Speaking)

On a previous article that I wrote in 2012, I mentioned 4 programming languages that you should be learning when it comes to the development of clinical trials. Why is this important, you may ask? Clinical Trials is a method to determine if a new drug or treatment will work on disease or will it be beneficial to patients. Anayansi Gamboa - Clinical Data Management Process If you have never written a line of code in your life, you are in the right place. If you have some programming experience, but interesting in learning clinical programming, this information can be helpful.

But shouldn’t I be Learning ________?

Here are the latest eClinical programming languages you should learn:

1. SAS®: Data analysis and result reporting are two major tasks to SAS® programers. Currently, SAS is offering certifications as a Clinical Trials Programmer. Some of the skills you should learned are:

  • clinical trials process
  • accessing, managing, and transforming clinical trials data
  • statistical procedures and macro programming
  • reporting clinical trials results
  • validating clinical trial data reporting

2. ODM/XML: Operational Data Modeling or ODM uses XML to build the standard data exchange models that are being developed to support the data acquisition, exchange and archiving of operational data.

3. CDISC Language: Yes. This is not just any code. This is the standard language on clinical trials and you should be learning it right now. The future is here now. The EDC code as we know it will eventually go away as more and more vendors try to adapt their systems and technologies to meet rules and regulations. Some of the skills you should learn:

  • Annotation of variables and variable values – SDTM aCRF
  • Define XML – CDISC SDTM datasets
  • ADaM datasets – CDISC ADaM datasets

CDISC has established data standards to speed-up data review and FDA is now suggesting that soon this will become the norm. Pharmaceuticals, bio-technologies companies and many sponsors within clinical research are now better equipped to improve CDISC implementation.

Everyone should learn to code

Therefore, SAS® and XML are now cooperating. XML Engine in SAS® v9.0 is built up so one can import a wide variety of XML documentation. SAS® does what is does best – statistics, and XML does what it does best – creating reportquality tables by taking advantage of the full feature set of the publishing software. This conversation can produce report-quality tables in an automated hands-off/light out process.

Standards are more than just CDISC

If you are looking for your next career in Clinical Data Management, then SAS and CDISC SDTM should land you into the right path of career development and job security.

Conclusion: Learn the basics and advanced SAS clinical programming concepts such as reading and manipulating clinical data. Using the clinical features and basic SAS programming concepts of clinical trials, you will be able to import ADAM, CDISC or other standards for domain structure and contents into the metadata, build clinical domain target table metadata from those standards, create jobs to load clinical domains, validate the structure and content of the clinical domains based on the standards, and to generate CDISC standard define.xml files that describes the domain tables for clinical submissions.

Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica – Open Source and Oracle Clinical.

Disclaimer: The legal entity on this blog is registered as Doing Business As (DBA) – Trade Name – Fictitious Name – Assumed Name as “GAMBOA”.

Source:

SAS Institute
CDISC

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Project Plan: CDISC Implementation

CDISC standards have been in development for many years. There are now methodologies and technologies that would make the transformation of non-standard data into CDISC-compliance with ease. Clinical trials have evolved and become more complex and this requires a new set of skills outside of clinical research – Project Management.

As with many projects, CDISC is a huge undertake. It requires resources, technology and knowledge-transfer. The industry (FDA for example) has been working on standardization for years but on September 2013, it became official, in which the FDA released a ‘Position Statement‘.

So what is CDISC? We can say that it is way of naming convention for XPT files, or field names naming conventions or rules for handling unusual data. Currently, there are two main components of CDISC: SDTM (Study Data Tabulation Model) and aDAM (Analysis Data Model).

As a project manager and with the right tool, you can look to a single source project information to manage the project through its life-cycle – from planning, through execution, to completion.

1) Define Scope: This is where you’re tested on everything that has to do with getting a project up and running: what’s in the charter, developing the preliminary scope, understanding what your stakeholders need, and how your organization handles projects.

The scope document is a form of a requirement document which will help you identify the goals for this project. It can also be used as a communication method to other managers and team members to set the appropriate level of expectations.

The project scope management plan is a really important tool in your project. You need to make sure that what you’re delivering matches what you wrote down in the scope statement.

2) Define Tasks: we now need to document all the tasks that are required in implementing and transforming your data to CDISC.

Project Tasks  (Work packages) Estimates (work unit)
Initial data standards review 27
Data Integrity review 17
Create transformation models 35

The work breakdown structure (wbs) provides the foundation for defining work as it relates to project objectives. The scope of work in terms of deliverables and to facilitate communication between the project manager and stakeholders throughout the life of the project. Hence, even though, preliminary at first, it is a key input to other project management processes and deliverables.

3) Project Plan: Once we completed the initiation phase (preliminary estimates), we need to create a project plan assigning resources to project and schedule those tasks. Project schedules can be presented in many ways, including simple lists, bar charts with dates, and network logic diagrams with dates, to name just a few. A sample of the project plan is shown below:

project plan sample
image from Meta‐Xceed paper about CDISC

4) Validation Step: Remember 21 CFR Part 11 compliance for Computer Systems Validation? The risk management effort is not a one-time activity on the project. Uncertainty is directly associated with the change being produced by a project. The following lists some of the tasks that are performed as it pertains to validation.

  • Risk Assessment: Different organizations have different approaches towards validation of programs. This is partly due to varying interpretations of the regulations and also  due to how different managers and organizations function. Assess the level of validation that needs to take place.
  • Test Plan: In accordance with the project plan and, if not, to determine how to address any deviation. Test planning is essential in:  ensuring testing identifies and reveals as many errors as possible and to acceptable levels of quality.

test plan-cdisc

  • Summary Results: This is all the findings documented during testing.

An effective risk management process involves first identifying and defining risk factors that could affect the various stages of the CDISC implementation process as well as specific aspects of the project. riskplan

5) Transformation Specification: Dataset transformation is a process in which a set of source datasets and its variables are changed to  meet new standard requirements. Some changes will occur during this step: For example, variable name must be 8 chars long. The variable label must not be more than 40 chars in length. Combining values from multiple sources (datasets) into on variable.

6) Applying Transformation: This is done according to specification however, this document is active during the duration of a project and can change. There are now many tools available to help with this tasks as it could be time consuming and resource intensive to update the source code (SAS) manually. Transdata, CDISCXpres, SAS CDIDefine-it; just to name a few.

7) Verification Reports: The validation test plan will detail the specific test cases that need to be implemented  to ensure quality of the transformation. For example, a common report is the “Duplicate Variable” report.

8) Special Purpose Domain: CDISC has several special purpose domains: CO (comments), RELREC (related records or relationship between two datasets) and SUPPQUAL (supplemental qualifiers for non-standards variables).

9) Data Definition Documentation: In order to understand what all the variables are and how they are derived, we need a annotation document. This is the document that will be included during data submission. SAS PROC CONTENTS can help in the generation of this type of metadata documentation. The last step in the project plan for CDISC implementation is to generate the documentation in either PDF  or XML format.

CDISC has established data standards to speed-up data review and FDA is now suggesting that soon this will become the norm. Pharmaceuticals, bio-technologies companies and many sponsors within clinical research are now better equipped to improve CDISC implementation.

Need SAS programmers? RA eClinica can help provide resources in-house / off-shore to facilitate FDA review by supporting CDISC mapping, SDTM validation tool, data conversion and CDASH compliant eCRFs.

Disclaimer: The legal entity on this blog is registered as Doing Business As (DBA) – Trade Name – Fictitious Name – Assumed Name as “GAMBOA”.

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Features of Success

What is it that makes one person succeed and another fail when the two seem to have about equal ability?  Some have said that the difference is in the amount of motivation and effort each brings to the job.  Others have said that an intent to become excellent is the main difference.

At least four items likely to have a vital effect on our success:

  1. basic ability
  2. a desire to excel
  3. an aim to succeed
  4. and zestful effort

If any one of these is absent or at a low level, our chances for success are lessened. These features, however, can be developed if we wish.

anayansi gamboa team building

Are you consider yourself a successful person?  Share your thoughts on the comment below.

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Recent Device Approvals: LifeVest Wearable Cardioverter Defibrillator

Recent Device Approvals: LifeVest Wearable Cardioverter Defibrillator

The FDA has recently approved the LifeVest Wearable Cardioverter Defibrillator to be marketed. The Zoll LifeVest is a wearable cardioverter defibrillator to monitor and treat dangerous, abnormally fast heart rhythms. These abnormal rhythms can lead to a complete absence of heartbeat (sudden cardiac arrest) and death (sudden cardiac death) if they are not treated. This device was first approved for patients 18 years of age and over in 2001, and it is now available for children.

The LifeVest is worn outside the body day and night. It treats abnormal rhythms by applying a high energy shock similar to that of a traditional defibrillator.

U.S. Food & Drug Administration (FDA) Clinical Pharmacology Corner Update: FDA Approves PORTRAZZA (necitumumab)

U.S. Food & Drug Administration (FDA) Clinical Pharmacology Corner Update: FDA Approves PORTRAZZA (necitumumab)

Clinical Pharmacology Corner Banner

*FDA Approves PORTRAZZA (necitumumab) in Combination with Gemcitabine and Cisplatin, for First-Line Treatment of Patients with Metastatic Squamous Non-Small Cell Lung Cancer*

On November 24, 2015, the United States Food and Drug Administration (FDA) approved PORTRAZZA (necitumumab) in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC). PORTRAZZA is not indicated for treatment of non squamous NSCLC. The approved recommended dosage of PORTRAZZA is 800 mg as an intravenous infusion over 60 minutes on Days 1 and 8 of each 3-week cycle (Q3W) prior to gemcitabine and cisplatin infusion. Patients receiving PORTRAZZA should be pre-medicated as follows:

* For patients who have experienced a previous Grade 1 or 2 infusion-related reaction (IRR), pre-medicate with diphenhydramine hydrochloride (or equivalent) prior to all subsequent PORTRAZZA infusions.
* For patients who have experienced a second Grade 1 or 2 occurrence of IRR, pre-medicate for all subsequent infusions, with
diphenhydramine hydrochloride (or equivalent), acetaminophen (or equivalent), and dexamethasone (or equivalent) prior to each PORTRAZZA infusion.

_Mechanism of Action (MOA), General Pharmacokinetics (PK) and Pharmacodynamics (PD) of Necitumumab_

* /MOA:/ Necitumumab is a recombinant human IgG1 monoclonal antibody that binds to the human epidermal growth factor receptor (EGFR) and blocks the binding of EGFR to its ligands.
* /Dose proportionality:/ Necitumumab PK is characterized by a target-mediated drug disposition, exhibiting dose-dependent kinetics on total clearance and steady state volume of distribution. * /Accumulation:/ Steady state exposure is achieved after 3 cycles of treatment.
* /Terminal half-life (mean):/ Approximately 14 days.
* /Exposure-safety:/ No apparent relationship between average serum necitumumab concentrations (C_ss,ave ) and all grades
hypomagnesemia, rash, arterial (ATE) or venous (VTE) thromboembolic events.

_Drug Interaction Potential_

* Coadministration of necitumumab (800 mg) with gemcitabine (1250 mg/m^2 ) and cisplatin increased the geometric mean dose-normalized gemcitabine AUC by 22% and C_max by 63% compared to administration of gemcitabine and cisplatin alone. This increased exposure to gemcitabine may have contributed to the higher toxicity observed with the necitumumab containing arm. The coadministration of necitumumab did not have an effect on the exposure to cisplatin (as measured by dose-normalized AUC_0-5h and dose-normalized Cmax for total platinum) in the presence of gemcitabine.
* Gemcitabine and cisplatin have no effect on the exposure to necitumumab.

_Use in Specific Populations_

The following population characteristics were not associated with a clinically significant effect on the PK of necitumumab: age (range: 19-84 years), sex (75% male), race (85% Whites), renal function [as measured by Cockcroft-Gault creatinine clearance (CL_cr ), range:11-250 mL/min] or hepatic function [as measured by alanine aminotransferase (range: 2-615 U/L), aspartate aminotransferase (range:1.2-619 U/L) and total bilirubin (range: 0.1-106 μmol/L). Body weight is identified as a covariate in the population PK analysis; however, weight-based dosing is not expected to significantly decrease the variability in exposure. No dose adjustment based on body weight is recommended.

_Efficacy and Safety_

The efficacy and safety of necitumumab at the recommended dose were demonstrated in an open-label, global, multi-center, 2-arm, randomized trial in 1093 patients with squamous NSCLC (Trial JFCC [SQUIRE]). A 1.6-month improvement in median overall survival (OS) among patients in the gemcitabine/ cisplatin + necitumumab Arm compared with those in the gemcitabine/cisplatin Arm (HR = 0.842 [0.736, 0.962]; p=0.012) was demonstrated. The most common adverse reactions (all grades) observed in PORTRAZZA-treated patients at a rate of greater than or equal to 30% and greater than or equal to 2% higher than gemcitabine and cisplatin alone arm were rash and hypomagnesemia. Cardiopulmonary arrest and/or sudden death occurred in 3% of patients treated with PORTRAZZA in combination with gemcitabine and cisplatin. Closely monitor serum electrolytes, including serum magnesium, potassium, and calcium, with aggressive replacement when warranted during and after PORTRAZZA administration.

Medical Device Safety and Recalls: eVent Medical LS, 5i, or 7i Inspiration Ventilators May Shut Down without Alarm

Medical Device Safety and Recalls: eVent Medical LS, 5i, or 7i Inspiration Ventilators May Shut Down without Alarm

A recall has been issued for eVent Medical LS, 5i, or 7i Inspiration Ventilators. eVent Medical is recalling the LS, 5i, or 7i Inspiration ventilators because a faulty switch on the ventilators’ power board may fail, causing the ventilator to shut down without sounding an alarm. If the ventilator shuts down, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death. The company has received one report of this issue occurring, with no injuries and no deaths. For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm475862.htm

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