Category Archives: Data Management

Data Management Plan – Coding and Reconciliation

All Adverse Events and Previous/Concomitant Medication should be coded and/or approved prior and during the trial.

Before adverse event terms can be reported or analyzed, they must be grouped based on their similarities. For example, headache, mild headache and acute head should all be counted as the same kind of event. This is done by matching (or coding) the reported adverse events against a large codelist of adverse events which is also known as dictionary or thesaurus.

Test cases and other documentation associated with the testing of auto-coding should be produced/documented.  This documentation is not part of the plan. It is a product of the design process and should be filed separately in the TMF system.

In the DMP. you should document the variables and the dictionary to be used.

For Concomitant Medications, WHO drug reference list is used.  Also document the version used and if applicable, the final version of the who drug (for trials running over 6 months).

For Adverse event, MedDRA dictionary is the choice of coding method. Document the version used.

Serious Adverse Event (SAE) Reconciliation:

Indicate SAE Reconciling Approach to be used to compare SAE database (e.g. Argus) to the Clinical study| database (e.g. EDC):

  • Indicate tools to be used
  • Location of SAE data
  • Planned timing
  • Planned frequency of SAE Reconciliation activities

What to look for during reconciliation:

  • There are matched cases but minor differences such as onset date
  • Case found in the CDMS but not in the SAE system
  • Case found in the SAE system but not in the CDM system

Methods for Reconciliation:

For electronic-automatic reconciliation between systems, there are some challenges you need to identify first such as which type of data is to be reconciled and then which fields to compare. Best practice is to reconciled those considered serious according to regulatory definitions.

For manual reconciliation, reports such as SAS listings extracted from both systems with study information, subject or investigator and other key data can be used to perform manual review.  A manual comparison of the events can then assure that they are both complete and comparable.

Central Coding Anayansi Gamboa
Central Coding

No matter which method you used for reconciliation, each type of data (eg, AE, MedHist, Conmed) should document which glossaries and version were used.

When data from the clinical trial database is entered into a drug safety database for coding, the data between the two systems should be reconciled to verify the data in both systems are

identical. The processes and frequency of reconciliation should be specified.

Source:

DIA -A Model Data Management Plan StandardOperating Procedure: Results From

the DIA Clinical Data Management Community, Committee on Clinical Data Management Plan

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“Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.”

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, Medrio, IBM eCOS, OpenClinica Open Source and Oracle Clinical.

Data Management Plan – Study Specific Documents

Data Management personnel are responsible for creating, collecting, maintaining and/or retaining all essential study documents when contracted by the sponsor (e.g. biotech company, big pharma client).

It is important to keep electronic and paper records or hard-copies and specify retention records of these essential documents:

  • Final version including amendments of the clinical protocol
  • Final version of the CRF/eCRFs
  • Final version of the completion guidelines
  • All final approvals and written authorization (e.g. emails or note to files).
Study Specific Anayansi Gamboa
Study specific

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“Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.”

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, Medrio, IBM eCOS, OpenClinica Open Source and Oracle Clinical.

Data Management Plan – Database Archive

Indicate how you intend to archive and share your data and why you have chosen that particular option.

The DMP should outline specific information regarding the organization’s procedures for archiving the electronic records.

Good practice for digital preservation requires that an organization address succession planning for digital assets.

Which criteria will you use to decide which data has to be archived? What should be included in the archive?

Type of data (raw, processed) and how easy it is to reproduce it. Also consider archiving audit trails as long as the records are (CRF Part 11, Section 11.10).

Does the archive have specific requirements concerning file formats, metadata etc.

It is recommended to use open source formats such as PDF-PDF/A, ODM-XML or ASCII type of files.

anayansigamboa

 

 

 

 

Who is responsible for the data after the project ends?

Sponsor, CRO, Vendor? All should be documented on the DMP. Once database is locked, within a reasonable time and after data submission to a regulatory agency, you want to archive your database for long term storage and recovery.

While most data submitted to regulatory agencies are available in SAS formats, there may be times when going back to the original data format may be required.

Even though the easiest way to make sure data is available after database lock is to archive this data in the built in structure as the current system. For example, for Medidata Rave studies, trials are built on on top of SQL server, hence, you should consider archiving the old studies in a compatible format of SQL Server, without any transformation or data manipulation = raw data.

Other formats for data archive can be considered are ODM XML, PDF-PDF/A or ASCII A-8. These are some options for long=term storage. FDA says in the guidance document for 21 CFR Part 11, ‘scope and application – section C.5″, “FDA does not intend to object inf you decide to archive required records in electronic format to nonelectronic media….As long as predicate rule requirements are fully satisfied and the content and meaning of the records are preserved and archived, you can delete the electronic version of the records”.

Archival Plan

For archiving data, this plan should list all the components of the orginal system that will be included in the archive and the formats being used for their storage.

The best practices for clinical data archiving in clinical research are no different from those for archiving any other kind of industry.

 

 

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“Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.”

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 – Protocol Summary

This usually describes the management plan for the data collected  during the project. It is a brief description or synopsis of  the protocol.

The protocol, in terms of a clinical research study, is the plan, or blueprint, that
describes the study’s objectives, methodology, statistical considerations, and the organization of the study. [CDISC.org Oct. 2012]

Protocol Summary
Protocol Summary – current state of ‘standardization’ of a protocol document

 

 

 

 

 

 

 

 

 

 

 

 

 

What to look for when reading a protocol?

  • Review of T&E – Time and Event Schedule or Visit Schedule.
  • Assessments e.g. ECGs, PE (physical exams), MH-MedHix or Medical HIstory, labs and more.
  • Critical data variables for analysis. e.g. efficacy and safety data

 

proc print data= work.demog;
where patient in(“&pid”) and page=’3′;
var patient SBJINT page
dob sex bmi weight height;
title ‘Page 3 – Demog’;
run;

-FAIR ;USE-
“Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.”

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, Medrio, IBM eCOS, OpenClinica Open Source and Oracle Clinical.

 

How to document the testing done on the edit checks?

Since the introduction of the Electronic Data Capture (EDC) in clinical trials where data is entered directly into the electronic system, it is estimated that the errors (e.g. transcription error) have been reduced by 70% [ Clinical Data Interchange Standards Consortium – Electronic Source Data Interchange 2005].

The Data Management Plan (DMP) defines the validation test to be performed to ensure data entered into the clinical database is complete, correct, allowable, valid and consistent.

Within the DMP, we find the Data Validation Plan. Some companies call it ‘DVS’ others ‘DVP’.  The Good practices for computerized systems in regulated GxP environments defines validation as a system that assures the formal assessment and reporting of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, qualification, maintenance, and retirement.

As an {EDC} Developer or Clinical Programmer, you will be asked to:

  • Develop test scripts and execution logs for User Acceptance Testing (UAT).
  • Coordinate of UAT of eCRF build with clinical ops team members and data management and validating documents, included but not limited to: edit check document, issue logs, UAT summary report and preparation and testing of test cases.

Remember not every EDC system is alike. Some systems allow you to perform testing on the edit checks programmed; others allow you to enter test data on a separate instance than production (PROD).

Data Validation and UAT Module.png

For example, some EDC systems facilitate re-usability:

  1. There is a built-in test section for each study – where data can be entered and are stored completely separate from production data. This allows you to keep the test data for as long as needed to serve as proof of testing.
  2. The copy function allows for a library of existing checks (together with their associated CRF pages) to be copied into a new study. If there are no changes to the standard checks or pages then reference can be made back to the original set of test data in a standards study, thus reducing the study level overhead.
  3. The fact that many of the required checks (missing data, range checks, partial dates etc.) do not require the programming of an edit check at all. Each of these and many others are already there as part of the question definition itself and therefore do not need any additional testing or documentation for each study.

If you have not documented, you have not done it-FDA

The “ideal world” scenario would be to reduce the actual edit check testing by the system generating a more “human readable” format of the edit checks. The testers that way would not have to test each boundary conditions of the edit checks once the system is validated. All they would have to do is inspect the “human readable” edit checks vs the alerts and would also be easy for the clients to read and sign off.

You can leverage the EDC systems audit trail under certain conditions. First of all – the system you are testing with must be validated in itself. Some EDC products are only ‘validated’ once a study is built on top of them – they are effectively further developed as part of a study implementation process – in this situation, I would doubt you could safely use the audit trail.

Secondly, you need to come up with a mechanism whereby you can assure that each edit check has been specifically tested – traceability.

Finally, you need to secure the test evidence. The test data inside the EDC tool must be retained for as long as the archive as part of the evidence of testing.

The worst methods in my view are paper / screenshot based. They take too long, and are largely non-reusable. My past experience has been creating test cases using MS Word then performing each step as per test case and take a screenshot, where indicated. Then attached to the final documentation and validation summary. This obviously a manual and tedious process. Some companies create test cases using HPQC or similar tool. This is a bit more automated and traceable yet, it is still prone for errors. It is better than documenting using MS Word or Excel but it is still a manual process.

Re-usability is what it is all about, but, you need to ensure you have methods for assuring the test evidence produced for edit checks you are reusing is usable as part of the re-use exercise.

Edit Check Design, Development and Testing is the largest part of any typical EDC implementation. Applying methods to maximize quality and minimize time spent is one of the areas I have spent considerable time on over the last couple of years.

For additional tips on writing effective edit checks please go here -Effective edit checks eCRFs.

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

Source images: provided courtesy of Google images.

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“Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.”

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.

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

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.

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.

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

Let’s Talk Clinical Research Organization (CRO)

And the winner of the Worst “CRO” goes to?

Did you think I would tell? Besides, you would think it is my opinion and not a fact. I spent most of my career working directly with sponsors (pharmaceuticals, biotechnology companies and healthcare organizations) in their goal to submit drugs for FDA approvals.

So why would I think clinical research organizations aka CROs are that bad? They help sponsors with tasks, they themselves do not have the capacity or the resources or the time for.

Let’s examine some CROs (names replaced):

CRO Q: Back in the day, I used to hear ex-employees of this CRO talk about this CRO as “a  sweatshop (or sweat factory)”. It was a good place to gain experience and move on. This CRO is still in business and with a lot of sponsor’s project. I guess, things just stay the same as long as it does not hit the bottom line ‘$$$$$‘.

CRO T: This CRO has been around under multiple names. As soon as their employees hear the phrase ‘we lost a big project’ or ‘we are about to merge again’, employees move on or leave this company.

CRO C: This CRO model is to leased out their own staff (more like a recruitment agency) than a CRO. I used to know someone who was transferred from Europe to USA under this CRO. Eventually, my friend move on into a pharma client and it is happy ever since. Why would anyone want to work for this CRO and let them leased out your skills and services when you could just register as a business and do it yourself?

If you google around, you will see many questions about salary, interviews, and career options but there are no discussion of the various work environments you might encounter at a CRO.

CRO B: I briefly worked for this small CRO and let me tell you. It has got to be the worst experience yet. Not only managers are like total control-freaks aka ‘micro-management’ but their unhealthy work environment can make you sick (open-floor). There was no sense of team work. How can you work on this kind of environment? I prefer consulting, home-based projects for reasons like this one.

I have no time for bad-managers.

CRO P: The people at this CRO that have been there the longest are the ones that make it such a horrible place to work and there are only a few of them. High turnover CRO with a passive aggressive/sabotaging culture.

CRO I: What happened to the word ‘paperless’? Instead, manual review, re-work and more paper is available. In the world where technology has advanced, this CRO still using old technologies where paper-based process are implemented for EDC-based clinical trials.

CRO P: If you have a degree in chaos, a knack for scapegoating and the top notch ability to kiss the clients ass, this is the place for you. I am not saying this, by the way. I found it online and it sure made me laugh.

CROs All: These CROs who want you to account for every minute of your day. They produce nothing, they leased out your skills and experience to the sponsors. If the sponsor goes, you might be laid off.

Discussing our clinical research experiences at different CROs is the bread and butter of this industry. With so many outsourcing, mergers, who could you work for?

As one CRA posted online “deciding which CRO to call home in the current job booming environment is more difficult than before. The CROs (especially the mid-size and large ones) are filling up all the Internet job search websites with their multiple job postings. And if you talk to any of the recruiters, they will confirm that the company they represent is the best fit for you, they value their people, have an excellent health/dental/vacation day package, and have the hard to find “work/life balance” that eludes us all. Well, the sad truth is that there is no ideal CRO fitting that description. Oh, some have their merits (and some are better than others, for sure), but ideal they are not.”

I could not have agreed better with her point of view. With all the mergers and changes in the industry in the last few years, there is a new landscape to explore.

CROs have a bad reputation for ‘high turnover’. It is too bad that this issue of turnover is not addressed from the Top level. Management is probably too busy worrying about their multi-million dollars bonuses that what is going on at the office.

Good luck and hope this article brought you some insights to the clinical research world we live in.

For a better career solution, joining an employee-owned culture is best. There a few in the industry. I represent RA eClinica.

Our company was founded on the belief that those who contribute to the company’s success should own a stake in the company and benefit from its success. Because each of us has such a high degree of trust in one another we are all more motivated to please each other and to do excellent work. We are constantly striving for perfection, together.

If you want to take charge of your life, career and freedom, join us in this quest. Note that we are not a CRO nor an EDC vendor. We would like to think of us as ‘where Clinical Research meets Technology”.

Source: MedZilla

Source: LinkedIn Pulse