Is this the worst disaster in Clinical Research (Drug)?

In the 1950s, thalidomide cut a wide swath of destruction across the world, leaving behind thousands of deformed infants, but that was only the beginning of the story. Thalidomide – known as Contergan in Germany – is still being used as a drug. This, even after the medication caused thousands of birth defects six decadesContinue reading “Is this the worst disaster in Clinical Research (Drug)?”

Clinical Trials – Computerized Systems

The Food and Drug Administration (FDA) established the Bioresearch Monitoring (BIMO) program of inspections and audits to monitor the conduct and reporting of clinical trials to ensure that data from these clinical trials meet the highest standards of quality and integrity and conform to FDA’s regulations. Computerized systems used in clinical trials refer to theContinue reading “Clinical Trials – Computerized Systems”

Got Medrio? The Next Best EDC…

Medrio is a low cost solution that offers easy mid-study                changes and intuitive phase I workflows. One of my favorite features of Medrio is the Skip logic functionality. So what is Skip logic? Let’s demonstrate this feature by using the Demography form / Race field: In many EDC systems that I am currently using orContinue reading “Got Medrio? The Next Best EDC…”

Freelancer / Consultant / EDC Developer / Clinical Programmer

* Setting up a project in EDC (Oracle InForm, Medidata Rave, OpenClinica, OCRDC) * Creation of electronic case report forms (eCRFs) * Validation of programs, edit checks * Write validation test scripts * Execute validation test scripts * Write custom functions * Implement study build best practices * Knowledge of the process of clinical trialsContinue reading “Freelancer / Consultant / EDC Developer / Clinical Programmer”

Understanding Audit Trail Requirements in Electronic GxP Systems

Computerized systems are used throughout the life sciences industry to support various regulated activities, which in turn generate many types of electronic records.  These electronic records must be maintained according to regulatory requirements contained within FDA’s 21 CFR Part 11 for US jurisdictions and Eudralex Volume 4 Annex 11 for EU jurisdictions.  Therefore, we must ensureContinue reading “Understanding Audit Trail Requirements in Electronic GxP Systems”

How to Avoid Electronic Data Integrity Issues: 7 Techniques for your Next Validation Project

The idea of this article was taking (with permission from the original authors) from Montrium:  how-to-avoid-electronic-data-integrity-issues-7-techniques-for-your-next-validation-project Regulatory agencies around the globe are causing life science companies to be increasingly concerned with data integrity.  This comes with no surprise given that Guidance Documents for Data Integrity have been published by the MHRA, FDA (draft), and WHO (draft).  In fact,Continue reading “How to Avoid Electronic Data Integrity Issues: 7 Techniques for your Next Validation Project”

Top 3 Posts at (EDC Developer)

Fist, I would like to thank everyone who has read articles posted at {EDC} Developer. Especially, my colegas and friends from India. The highest reading and hits have come from people living in India. New to the industry? Want to get in as clinical data manager or clinical programmer? Looking for a particular topic orContinue reading “Top 3 Posts at (EDC Developer)”

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 byContinue reading “Data Management Plan – Coding and Reconciliation”

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 versionContinue reading “Data Management Plan – Study Specific Documents”

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 decideContinue reading “Data Management Plan – Database Archive”