Tag Archives: Biotechnology and Pharmaceuticals

Glowing proof of vaccination

A new vaccine delivery method allows doctors to scan a person’s skin and instantly see if that person has been injected with a certain vaccine. What sounds like science fiction, I assure you is very real.

For years, Bill Gates has been writing checks to people who have been developing the ability to track which individuals have received a vaccine with a digital tattoo invisible to the naked eye but scannable by a modified smart phone.

This is not something Bill Gates is trying to hide. “We will have some digital certificates to show who has recovered or been tested recently or, when we have a vaccine, who has received it,” he said publicly.

Scientists are already exploring using this patch delivery system for the COVID-19 vaccine. It would be dye and vaccine that are delivered at the same time in a “bandage-like patch” of microneedles that could be quickly scanned to show who has or has not received the vaccination.

Let our political leaders know that free Americans will not stand to be tagged like rows of farm pigs awaiting slaughter. Now is the time to stop this. – Mat

Rice University professor Kevin McHugh Ph.D. is the inventor of this vaccine/tattoo technology. He describes the technology as “quantum dot tattoos” and calls it a “tag” in his article:

The tags are incorporated in only some of the array of sugar-based microneedles on a patch. When the needles dissolve in about two minutes, they deliver the vaccine and leave the pattern of tags just under the skin, where they become something like a bar-code tattoo.

Instead of ink, this highly specific medical record consists of copper-based quantum dots embedded in biocompatible, micron-scale capsules. Their near-infrared dye is invisible, but the pattern they set can be read and interpreted by a customized smartphone.

It should come as no surprise that the Bill and Melinda Gates Foundation was pushing for this chilling technology. They were the ones that were paying for it. And now they are the ones talking about this technology as a response to COVID-19 that “everyone” needs to participate in.

It would take a tiny design change to give everyone a unique, invisible tag number and track each person without them even knowing it. Will you stand to be earmarked with one of Bill Gates’ permanent markers? Or will you stand with me today to fight against this level of surveillance of unaware Americans?

But Bill Gates wants to go much further. Already, the UK government is in talks with Onfido, an ID verification company to connect biometrics with immunity (through recovery or vaccination). Bill Gates has put 50 million dollars toward this company and its efforts. And India is well on its way to bio-IDs for everyone in the nation.

“Eventually what we’ll have to have are certificates of who’s a recovered person, who’s a vaccinated person,” said Bill Gates. These are being called “immunity passports,” and they will allow or block people from entry to areas based on whether they have had the virus that Gates is intensely working to develop.

Right now, the level of surveillance that people in America are prepping for is astonishing. Chicago has already picked the locations and bought the needles to vaccinate the “whole” city and is trying to push their plans across the Midwest right now.

Vaccines have already been developed and are currently in human trials. We have a short window to make our voices heard before this becomes our new reality. Send your fax now to legislators and governors that are going to be under massive pressure to launch this vaccine and discriminate against anyone who does not take it.

Organizing a fight against this level of control of every American is only possible because of the friends and supporters who partner with Liberty Counsel Action to help us bring this to light.

Thanks to your partnership, we can educate and empower patriots across America to stop these dictators from destroying everything our Founding Fathers established. Now is not the time to get discouraged; now is the time to rise up, get encouraged, and get involved today.

I encourage you to join me in prayer for President Trump, right now. There is intense pressure on him to sacrifice our freedom for an illusion of safety. What I shared with you today will create even greater pressure on him. Pray for America right now and if you haven’t already, sign our petition to President Trump to protect our freedom in the hours, weeks, and months ahead.

Blessings,

Mat Staver
Chairman

P.S. We cannot silently hope someone else will restore our freedoms. It is up to us to stand for our liberties and protect our rights. Send a fax demanding that legislators and governors stop these unconstitutional surveillance efforts.

Right now is a challenging time for many of our usual friends and supporters. Please know that we pray for you. If you can support Liberty Counsel Action with a donation of any size today, we would deeply appreciate your partnership with us. God bless you.

Fair Use Notice: Images/logos/graphics on this page contains some copyrighted material whose use has not been authorized by the copyright owners. We believe that this not-for-profit, educational, and/or criticism or commentary use on the Web constitutes a fair use of the copyrighted material (as provided for in section 107 of the US Copyright Law).

Will vaccinations be forced on students?

Some schools and colleges are making plans requiring students to be vaccinated before they will reopen. Nationally recognized leaders are laying the groundwork to require vaccinations for American students. And pharmaceutical companies are rushing to produce a wide range of vaccines—before they know if they work or if they have unacceptable side-affects.

NOW is the time to educate our politicians and community leaders that vaccinations must be completely voluntary and NOT mandatory. Send a fax message to state and national leaders to protect our unalienable, God-given rights today. – Mat

Los Angeles Mayor Eric Garcetti told his city’s nearly 4 million residents to not “overreact” when he told them that Los Angeles would “never be completely open” until a vaccine is created and in use.

“I think we have to all recognize that we’re not moving beyond COVID-19,” Garcetti said. The truth is that many politicians don’t really want to move past COVID-19 because it has become a useful tool for increasing their power and control.

Garcetti is not alone. After hearing Dr. Anthony Fauci admit there probably wouldn’t be a vaccine before fall classes begin, California State University decided to cancel in-person fall classes for most of its 770,000 students.

In addition, a spokesperson for the University of California said, “it’s likely none of our campuses will fully re-open in the fall.” That system includes 10 sizeable campuses.

It makes sense that if educational institutions shut down their schools while waiting for a vaccine, it is likely they will turn away students who decline to take the “voluntary” vaccine these schools are waiting to see deployed.

If we do not stand up for our rights, state-run schools will have a perfect excuse to bar conservatives and limit the educational opportunities we have. Our children could easily be stripped of the freedom to pursue an education and all the opportunities it can bring under the guise of COVID-19 restrictions.

Schools have already largely developed their plans for this fall, have already decided who will staff their institutions and how they will move forward. There is no time to waste. Send a fax message to our state and national leaders that we demand personal freedom and truly voluntary vaccination policies … not mandatory vaccinations in order to obtain an education.

A task force in our nation’s capital is urging schools to remain closed until there’s a vaccine for COVID-19. The co-chairs of this task force are former Secretary of Homeland Security Michael Chertoff and former National Security Adviser Susan Rice. We are very concerned that as soon as a vaccination is approved, then everyone will be required to take it.

However, a recent poll from ABC/Washington Post said that 30% of people would not want to receive a COVID-19 vaccination, even if it was widely available and completely free.

Sadly, that leads to the question of whether bureaucrats will make the COVID-19 vaccination mandatory for anyone who wants to return to school.

NOW is the time to send a clear message to politicians to not hold education hostage to the dictates of people who want to mandate vaccinations for anyone who wants to attend a school.

Send a fax today to make our leaders understand that we will not bow as misguided officials make medical decisions for us based on what is best for their political interests!

Dr. Anthony Fauci is a key influence in setting the expectation for schools and medical facilities nationwide. He repeatedly emphasizes that we will not return to “normal.” He has said, “If this was a situation where we had a vaccine, that would be the end of that issue, in a positive way.”

Dr. Fauci and other leading vaccine advocates use deceptive words when they say that receiving the vaccine will be “voluntary” — that is only if you choose to stay home, give up grocery shopping, attending school, eating in restaurants and travelling. India has a “voluntary” tracing app, but India’s citizens quickly learned that the tracing app – which will be modified to include vaccination records at some point – is required if they want to go anywhere outside their own home.

NOW is the time to rise up and demand freedom for everyone who has concerns about a forced vaccine being pushed by Bill Gates, being rushed through trials and being implemented through government mandates.

Take your voice straight to the halls of Congress and demand freedom with a fax to the leaders who will be making such laws and issuing such orders.

Liberty Counsel Action is serving patriots like you across America by alerting you to upcoming battle lines being drawn in our nation. We are giving you a way to significantly impact the future for our children and grandchildren. We completely rely on your help to accomplish our mission of being “watchmen on the wall,” warning Americans about upcoming attacks on our God-given, inalienable rights.

Will you help support LCA with a gift today to keep us in this battle? Right now, we are exposing and confronting many elected and appointed officials and Big Pharma interests that have hundred of billions of dollars at stake. We need your support to bring the truth to Capitol Hill!

Thank you for your commitment and patriotic concern about the future of our nation!

Sincerely,

Mat Staver
Chairman

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US Biowarfare Act Author: Vaccines, Corruption, Coverups & Secret Bioweapon Programs

In a time of great confusion where so many possible scenarios of what we are seeing take place regarding the coronavirus outbreak, the origins of the virus and the severity of the pandemic, one is reminded of the quote from former CIA Director William Casey…

“We’ll know our disinformation program is complete when everything the American public believes is false.” While at this point we certainly do not claim to have all of the answers, we are working hard to provide alternative perspectives from top qualified experts and encourage the viewer to consider more than one possibility while having an open mind and draw your own conclusions. In this interview, Spiro is joined by the author of the US Biowarfare Act Professor Francis Boyle to discuss the latest developments regarding the Coronavirus outbreak, the source of the virus and the corrupt interests involved. Professor Boyle also outlines two reports which he claims to confirm his position on the origins of the virus. One, from a Nobel Peace Prize winning scientist in France. The second, a leaked memo from the 5 Eyes intelligence alliance.

Coronavirus NSW: Dossier lays out the case against China bat virus program https://www.dailytelegraph.com.au/cor…

Nobel winning scientist says COVID-19 originated in Wuhan lab https://www.neweurope.eu/article/nobe…

Injectable device delivers nano-view of the brain https://news.harvard.edu/gazette/stor…

French army returned from Wuhan military games in October with mystery illness https://www.mirror.co.uk/news/uk-news…

CDC Lifts Shutdown Order on Army Biolabs at Fort Detrick https://www.military.com/daily-news/2…

Canadian Scientist At Center Of Chinese Bio-Espionage Probe Found Dead In Africa? https://www.zerohedge.com/geopolitica…

Researcher killed in murder-suicide was working on a ’significant breakthrough” for coronavirus https://www.click2houston.com/news/na…

Secret Biological Weapons Program in the U.S.? PATRIOT Act Allows Violations of Bioweapons Law https://www.globalresearch.ca/secret-…

A SARS-like cluster of circulating bat coronaviruses shows potential for human emergence https://www.nature.com/articles/nm.39…

Top Military Research Lab Part of Worldwide Search for SARS Cure https://archive.defense.gov/news/news…

irst Interview With Professor Boyle https://www.activistpost.com/2020/02/…

Second Interview With Professor Boyle https://www.activistpost.com/2020/02/…

Source:

Spiro Skouras

How the Pharmaceutical Industry became into existence?

The Birth of the Pharmaceutical Industry can be traced back to 1850 – 1875 where the first “authentic” drug was developed by extracting agents from plants.

In those years, there were also developed the microbial theory of disease, medicines and homoeopathy patent and there heavy use of powerful purgatives and cathartics medicines.

By 1875, the Drug Development becomes a science and the first synthetic drug was introduced. By 1900, vaccines and antitoxins form the basis of the new pharmaceutical industry.

From 1900 to 1925, began what is now known as the pharmaceutical century. The U.S. Pure Food and Drugs Act was passed (known today as the FDA) and the development of hormonal and chemotherapy was introduced.

After 1925, it began what is known today as the Antibiotic and Regulatory Era. Vitamins, antimalarials, anticarcinogenic compounds and anti-infectives discoveries were made. The FDA gains independence as a regulatory agency and is given compliance responsibility.

From 1950 thru 1975, a new generation of the drug became apparent. Vaccines for polio became mandatory, oral contraceptives appears on the market and cardiovascular therapies.

Also, an amendment to the Federal Food Drug and Cosmetic Act of 1938 Act was signed by President Kennedy to ensure that consumers will not be the victims of unsafe and ineffective medications. Additional information about this Act can be read here: Kefauver-Harris Amendments

The Globalization of the Pharmaceuticals industry started from 1975 thru 2000. New drugs therapies, new antiviral drugs, and the development of new drugs by biotechnology companies were in global high demand.

By 2000, over 2.8 million people participated in over 50,000 clinical trials and more research and development funding was increased.

R&D Expenditures by Body System

R&D Expenditures

Cost (Billions) Body System
7.0 Central Nervous System
6.0 Cancer, endocrine and metabolic
4.5 Cardiovascular
3.5 Infectious Disease
2.5 Biological and vaccines
5.3 Other

Current Trends in the Industry since the late 2000s

Biotechnology Medicines
Drug Intervention Targets
Vaccines

 

Role of Generic Drugs
Generic drugs account for over 47% of prescription drugs in the market in which 43 major prescription drugs come off patent by 2005.

What does this mean for pharmaceutical drugs?
Between 40% – 60% of sales are lost to the generic brand within the two years of coming off patent.

Factors that will impact the R&D future:

  • There has been over 40 mergers and acquisitions since 1985
    • Sanofi and Synthelabo
    • Zeneca and Astra
    • Monsanto and Pharmacia
    • Roche and Genentech
  • Employment grew at a 3% rate per year

Total Drug Development Time (Years)

Summary:
On average, it takes at least ten years for a new medicine to complete the journey from initial discovery to the marketplace, with clinical trials alone taking six to seven years on average. The average cost to research and develop each successful drug is estimated to be $2.6 billion.

Pharmaceutical Regulation

In 1902, about 10 children die after receiving a vaccine shot. The BIOLOGICS CONTROL ACT was passed to ensure purity and safety of serums, vaccines and similar products used to prevent or treat diseases in humans.

In 1906, “The Great American Fraud” reveals patent medicines laced with addictive drugs, toxic additive and alcohol.

In 1912, Public outcry over the sales of “snake venom” and other wonder cures.  The SHERLEY AMEND was passed to prohibit labelling medicines with false therapeutic claims intended to defraud the purchaser.

In 1927, the government forms a separate law enforcement agency called the Food, Drug and Insecticide Agency.

In 1937, about 107 people, including many children die after drinking a syrup called Elixir of Sulfanilamide. Due to safety concerns, The Federal, Food, Drug and Cosmetic Act (1938) was passed as the first attempt to regulate cosmetics and medical devices.

In 1962, the sleeping pill “Thalidomide“, developed what is known today as Grunenthal Pharmaceutical in Germany, resulted in thousands of birth defects in Western Europe. The KEFAUVER-HARRIS Drug Amend was passed to ensure drug efficacy and greater drug safety.

In 1983, the ORPHAN DRUG Act was passed enabling the FDA to promote research and marketing of drugs needed for treatment of rare diseases. This year there as an outbreak of HIV / AIDS cases.

In 1988, The FOOD and DRUG ADMINISTRATION ACT were established as the FDA under the Department of Health and Human Services.

In 1992, the pharmaceutical industry complained that life-saving drugs were being reviewed too slowly by the FDA. The PRESCRIPTION DRUG USER FEE ACT (PDUFA) is made into law.

Source:

Image: Courtesy of Google image

FDA website

Private information for college researched in the 2000s.

EMA and The Netherlands Biopharm Opportunities

The European Medicines Agency (EMA) is relocating from London to Amsterdam.

According to EMA, the Seat Agreement allows EMA to function independently in the Netherlands. Similar agreements apply to other EU agencies located in the Netherlands.

On Friday, 13 April 2018, the Dutch Council of Ministers agreed to sign the document.

Amsterdam – EMA

Quantify research reported earlier this year that the shift of the EMA to Holland will be a welcome boon to that country, particularly due to some companies shuttering their Netherlands locations in favor of other European countries. The research report pointed to more than 1,500 job losses about eight years ago following Abbott and Merck Sharpe and Dohme closing facilities in that country. Between 2009 and 2014, Quantify said the Dutch market share in the European pharma industry plummeted from 3.3 percent in 2009 to 17 percent in 2014.

To help spur the resurgence of the Netherlands pharma industry, the Netherlands Foreign Investment Agency is hosting a landscape tour at the end of summer to showcase the country’s offerings. While the EMA is expected to become the core of the Netherlands biopharma industry, the NFIA said the country is home to facilities for more than 420 biopharmaceutical companies, such as AstraZenecaJanssen, MSD, Amgen and Teva, to name a few. The Netherlands Foreign Investment Agency pointed to the companies because they “rely on their Dutch operations for both R&D and distribution activities.”

But, it’s not just the large global pharma companies that have a home in Holland. The country is also home to a number of biopharmaceutical startups and scale-ups, like GalapagosGenmabPharming and uniQure.

Another company that will be relocating to the Netherlands is Gilead Sciences.  This new facility will be employing over 300 people. Other companies worth mentioning are GSK-Novartis, Merk and most well-known Clinical Research Organizations (CROs) have made the Netherlands their home.

For those interesting in working and living in Amsterdam, you should know that it is one of the countries with the highest taxes at a 52% income tax rate if you make over 55,000 euros per year (apparently they think this is good money). For a regular employee with benefits, your tax rate will be at a 42 %. Don’t expect to be making more than 55,000 euros a year unless you are a highly skilled employee or hold a managerial level position.

Tot Ziens!

Source:

Biospace

EMA

https://www.government.nl/latest/news/2018/04/23/the-european-medicines-agency-ema-and-the-netherlands-agree-on-seat-agreement

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Before Your Trial Goes Live – InForm FastStart

When EDC is used in a clinical trial, electronic case report form (e-CRF) data are defined to be the data that are manually entered into a computer by the patient or by the investigator’s staff.

CDISC defines e-CRF as a CRF in which related data items and their associated comments, notes, and signatures are linked electronically.

e-CRFs may include special display elements, electronic edit checks and other special properties or functions used for both capture and display of the linked data.

Prior to submitting a request – FastStart, you should throughly test your trial.

Technically speaking, FastStart requests ensures base is cooked when sending all UAT versions of the trial, Training and Production versions of the trial to Oracle implementation team. This will vary on the type of contract your company / sponsor has with them.

Your company or sponsor may have a setup of ‘Implementation’ instructions that will be provided to Oracle HSG (formerly PhaseForward) that includes all files, summary and instructions for each implementation. Some of these required files or special files are listed below.

Special Files:

Filename Contents
Customresources.XML Collects references to any html files that will be use to override standard InForm functionality within the trial. Includes the visit calculator (VISITCALCULATOR.HTML) and confirmation of enrollment message (ENROLLMENTCONFIRM.HTML).
InsertUsers.XML User details
InsertSites.XML Site details
InsertSiteGroups.XML Links users with specific sites
InsertGroups.XML Defines the properties and contents of groups e.g. queries, items
InsertRightsGroups.XML Groups multiple access rights, with details of specific users that are assigned those rights.Also contains details of any overrides to default levels of access at item level
InsertSignCRF.XML Defines form to be signed and group who have access to sign
Crbaffadavit.TXT Affadavit text which appears when signing the eCRF (used at eCRF level). The text is standard, but protocol number must be amended for each trial. NOTE: This file will be used for any trials using casebook level signatures.
logo.jpg Your company logo
EnrollmentOverride.htmlHomedefault.html Here you can modify your trial name

The eSignature is a replacement for the Investigator’s physical signature (paper form). This file captures confirmtion from the Investigator that he has reviewed and confirmed the information on each eCRF is accurate. This Affidavit text contains something like ‘I, Principal Investigator, for study 9999999, confirm I have reviewed this CRF form….’

Investigator– 21 CFR 50.3(d) defines the investigator as “The individual who actually conducts a clinical investigation – i.e., under whose immediate direction the test article is administered.”

Some recomendations about eSignature can be further research on Secure Access For Everyone (SAFE) standards. The goal is that once the investigator is credentialed by SAFE, his/her identity and electronic signature can be used by all SAFE compliant sponsors.

InsertUsers File

Training must be provided to sponsors users prior to granting access to an InForm trial. For example, CRAs will need to be well trained on all aspects of the EDC system in order to provide coaching for the investigator. This file documents all sponsors and site staff users within each clinical trial.

Easy, wasn’t it? Again, build your trial and test to make sure all files were cooked and working as expected. Log into your trial and ensure that the special files appear correctly. Enroll a subject to ensure the enrollment confirmation screen appears and, if used in the trial, the visit calculator appears.

Reference:

Electronic Clinical Data Capture, Position Paper Revision 1, May 1, 2005

How to manage Sites and Users in InForm Trial

Your comments and questions are valued and encouraged.
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.

ClinCapture® Tutorial – How to enter a patient schedule a visit and start entering data

ClinCapture® Tutorial – How to enter a patient, schedule a visit and start entering data – YouTube.

ClinCapture® is the most advanced open-source electronic data capture (EDC) system designed to streamline your clinical trials. As an open-source solution, ClinCapture® is tailored to meet the needs of life science companies looking to run cost-effective clinical trials.

ClinCapture® can be rapidly deployed and easily adopted, customizable to specific study requirements. ClinCapture® is repeatedly chosen as a preferred EDC solution because it is intuitive, flexible, and proven.

Source: Clinovo

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anayansi gamboa

How to Manage Sites and Users in InForm Trial?

So you created your first InForm Trial and now what? Before you can actually enter data into your trial, you need to set up a user management system which assigns permissions to different users in your system depending on their job “role”.

In InForm, this is accomplished by using a tool called ‘User Management Tool’ or simple UMT. This tool allows sponsor to manage sites and users once the trial have gone live. There may be many different user groups with different levels and ranges of permissions.

Creating an InForm Trial – UMT:

  1. Create your InForm trial in the UMT. I won’t go into details on how to actually do this and depend upon the contract agreement with the vendor (i.e. Oracle/PhaseForward); they will perform this task for you.
  2. Select Trial Version = latest InForm version (i.e. 5.0)
  3. Select Countries where this trial will take place
  4. Select Status. Each InForm trial has 4 main statuses.
    1. Fast Start = Pre-Go Live
    2. Fast Forward = Trial is now live
    3. Fast Lock = Trial is lock
    4. Decommission = Trial is completed/archived

Managing users and groups can be a tedious task but tools such as UMT makes them easier to manage.

Roles: Roles (e.g. CRA, PI, System Administrator, etc) are used to assign specific permissions to individual users or groups, typically to perform specific functions in the InForm system.

The system allows you to either manually enter a role or import using a template called ‘MUL’ or Masters Users List. If you decided to upload your rights and roles via MUL, the system will generate a log file. It is imperative that you check this file and check any errors before proceeding.

Once the roles have been added to the UMT, you need to approved them before you build your clinical trial. The system also comes with defaulted and approved rights and roles.

Another option available is to create what is called as ‘signature groups’. If you are familiar with Medidata Rave system, this is equivalent to checking the ‘Signature required’ box and setting the investigator signature in Architect project main page.

Common use of Signatures in clinical trials are at the form level (i.e. 1 signature per form or at the subject level or studybook = 1 signature per subject).

Item Groups: Items groups is used to overrides or restrict a particular user access to a form or field. This is equivalent to ‘Restrictions – View/Entry’ in Medidata Rave.

One good example of display override usage is the coding fields restrictions. If only Clinical Coders are allowed to view / entry data on those items, you will limit access to all roles but the coders role.

Here’s a snippet of the code in .XML:

<!–?xml version=”1.0″?>–>
<MEDMLDATA xmlns=”PhaseForward-MedML-Inform4″>
/*some other code goes here*/
<ITEMGROUP
GROUPNAME=”Hidden Coding Items”
GROUPDESCRIPTION=”Hidden Coding Items”>
<!– Insert ItemRef Names –>
<ITEMREF REFNAME=”PT_NAME”/>
<ITEMREF REFNAME=”HLGT_NAME”/>
<ITEMREF REFNAME=”HLT_NAME”/>
<ITEMREF REFNAME=”LLT_NAME”/>
<ITEMREF REFNAME=”SOC_NAME”/>
</ITEMGROUP>
</MEDMLDATA>

Two other important groups that you need to be aware of is the Query and the Report Groups. The former, as the name entails, allows a user to open, answer, reissue and close queries during the course of a clinical trial. The latter, allows a particular user to run reports.

For example, an Ad Hoc User can access Ad Hoc reports via Cognos. The roles associated to this group could be your project manager, Clinical Research Associate (CRA) or your Lead Data Manager (LDM/CDM).

Once you have completed your basic setup, you will need to prepare or cook those xmls files onto your clinical trial. The rights/roles we discussed needs to be in an approved status. You also want to make sure you ‘lock for QC’ or lock the trial to prevent anyone from making changes to already added sites/users.

Sites and Users marked for upload to InForm will automatically be cooked into your trial.

Last step we need to take is to generate the XML files by selecting the link ‘Generate InFormXML.’ Now, your UAT trial is created, your URL is set up and you are ready to perform User Acceptance Testing.

Remember to validate your XML files, especially if your clinical trial is running across several countries. I have found issues with foreign languages symbols or special characters entered in the UMT system. Avoid at all cost any special characters.

Source: User Management Tool Reference Guide from PhaseFoward

Your comments and questions are valued and encouraged.
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.

Data Management Plan in Clinical Trials

 

The preparation of the data management plan (DMP) is a simple, straightforward approach designed to promote and ensure comprehensive project planning.

The data management plan typically contains the following items. They are:

  1. Introduction/Purpose of the document
  2. Scope of application/Definitions
  3. Abbreviations
  4. Who/what/where/when
  5. Project Schedule/Major Project Milestones
  6. Updates of the DMP
  7. Appendix

The objective of this guidelines is to define the general content of the Data Management Plan (DMP) and the procedures for developing and maintaining this document.

The abbreviation section could include all acronyms used within a particular study for further clarification.

e.g. CRF = Case Report Form
TA = Therapeutic Area

The Who/What/Where/When section should describe the objective of the study specific data management plans for ABC study. This section provides detail information about the indications, the number of subjects planned for the study, countries participating in the clinical trial, monitoring guidelines (SDV) or partial SDV, if any CROs or 3rd party are involved in the study (e.g. IVRS, central labs), which database will be used to collect study information (e.g. Clintrial, Oracle Clinical, Medidata Rave or Inform EDC).

The Appendix provides a place to put supporting information, allowing the body of the DMP to be kept concise and at more summary levels. For example, you could document Database Access of team members, Self-evident correction plan, Data Entry plan if using Double-data entry systems or Paper-Based clinical trials systems.

Remember, this is a living document and must be updated throughout the course of the clinical trial.

If problems arise during the life of a project, our first hunch would be that the project was not properly planned.

Reference: Role of Project Management in Clinical Trials
Your comments and questions are valued and encouraged.
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.

To hire me for services, you may contact me via Contact Me OR Join me on LinkedIn

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

Reasons I Like My Job

It has been a little while since my last blog. I have been busy this summer with the acquisition of a new member of our family – a 7 weeks-old White Westie. I have been most of the summer taking him to the park, riding the bike to the local beach or lake in his mini doggie ride. On top of that, I have been busy with client projects and meetings.

With my job, I work as a consultant for pharmaceutical and biotechnology companies. So what makes this job special?

Experiences

As a consultant, I get the chance to work with many clients and projects. With each opportunity, I learn a new perspective and approach that has been taken to building various clinical databases that support clinical trials. There have been a number of occasions where problems between clients are similar and this similarity allows me to bring those experiences to the next client.

Challenge

My clients don’t often bring me in for the small and easy stuff. For that, their staff usually has the capacity to handle their needs. The time to turn to consultants is when the timelines or technical depth of the project requires outside help. Because of this, I often find myself on engagements that are relatively challenging. I can really take lessons from one client and apply them to all others.

I get exposed to things I already have ‘expertise’ in and I also get exposed to things I only know academically. I get to learn!

Mentoring

I love teaching. Being a consultant provides an excellent opportunity to do this. I have been working with a lot of clients in a mentoring relationship. Sometimes in person, sometimes via webex.
I like to think I made a difference for each and one of my employers/clients I have worked for.

Freedom

One bonus of working in the Pharmaceutical industry has been the ability to exercise a lot of freedom in choosing where to move my career. As my skills and interests have changed through the years, so too have my responsibilities and assignments.
So life has been busier in some ways but it has been more flexible.

I have had more scheduled flexibility than I ever had.

So until my next post, tell me why do you like your job?

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.