INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES
What Level Of Review Does Your Study Need?
The level of IRB review required for research involving human subjects depends on the study’s specific design and the risks involved. Some research must be reviewed by the fully convened IRB, while others may be reviewed by a designated IRB member. Some projects may not even require IRB review. By applying the same four-step evaluation process used by IRB members, research professionals can better plan for a study’s necessary level of review and save time in study startup.
Improving Compliance While Reducing Resources
A global sponsor organization that develops pharmaceuticals, biologics, medical devices and over-the-counter products, sought a better approach to clinical trial registration and results disclosure requirements in the US. Using templates and spreadsheets, the sponsor team was spending approximately 20 hours to draft, finalize, approve and release one initial study registration to the US clinical trial registry (www.clinicaltrials.gov).
Updates To The Guideline For Good Clinical Practice: Quick Review
In November 2016, for the first time in 20 years, ICH GCP was updated by means of an addendum that provides additional guidance without altering the existing text. Now that we are in the implementation phase of the ICH GCP revision, it may be a good idea for biotech and specialty pharma innovators to review the key principles of ICH GCP and how they have been updated to reflect the realities to today’s clinical trial landscape
From Laboratory To Bedside: Expediting Development Of Novel Rare Cancer Treatments
This webinar shares new insights on rare oncology drug development and examines how new processes and regulatory pathways are helping speed development of novel therapies.
Recent FDA Updates And Guidance For Rare Disease Drug Development Webinar
In January 2019, the US Food and Drug Administration (FDA) updated its 2015 draft guidelines for drug discovery in rare diseases. The update, Rare Diseases: Common Issues in Drug Development, seeks to help pharmaceutical companies and other sponsors perform more efficient development programs for drugs and biological products and provides new insights on complex elements of the development process. In this webinar, learn about the core elements of the new guidance plus the latest recommendations and instructions from the agency along with practical examples and applications.
With Investors’ Eyes On Biotechs, Biotechs Must Keep Their Eyes On Transparency
Small and mid-size pharmaceutical companies seeking funding or interested in being acquired up by a larger pharma company should not ignore the importance of disclosure, transparency and compliance when it comes to financial matters.
CCDS Or Local Labeling, A Chicken-And-Egg Situation?
In this blog, UBC’s Dr. Luca Cariolato, Sr. Safety Scientist, speaks to the importance of developing a Company Core Data Sheet (CCDS) before local safety information.
505 (b)(2) vs. ANDA: How Complex Drugs Fit In
Read how recently released draft guidance documents can provide clarity on abbreviated approval pathways and highlight priorities of the FDA to increase competition in the marketplace with a focus on speeding generic approvals, including complex generic drug products.
Ask The IRB Experts
Clinical research is complicated. At WCG, we frequently get questions about the ethical conduct of research from clinical team members at biopharma companies and study sites. We know that for many of the questions we get, the person asking is not the only one struggling with that issue. Read the questions your peers are asking – and if you don’t see yours, submit one of your own.
CLINICAL TRIAL REGULATORY SOLUTIONS
DIA 2019 Annual Meeting Schedule At A Glance
Download the at a Glance Schedule for DIA 2019 Global Annual Meeting - San Diego - June 23-27.
As the clinical development of new medical products becomes more complex, so has the route to regulatory compliance that ensures patient safety and regulatory compliance.
Electronic Trial Master Files
As life sciences companies move to semi-virtual environments keeping only the most vital functions in house, more and more Trial Master Files are being converted to an eTMF format.
DIA NOW In Focus
Learn more about DIA NOW In Focus on Pharmacovigilance, the scope of the content offered, and how it can help you keep current and gain insights into hottest Pharmacovigilance topics from around the world.
Pharmacovigilance System Master File
One of the many challenges in clinical trials, for both compounds and medical devices in development, is the need to rapidly communicate any potential safety concerns or findings, during pharmacovigilance, to all applicable regulatory authorities.