Clinical Research Solutions
How to Implement an Effective Audit Trail
Maintaining an audit trail is a regulatory compliance requirement, but what makes an audit trail beneficial for maintaining effectiveness and complying with regulations? This blog will explain what...
Clinical Research Solutions
How to Ensure Your Workforce is GMP Compliant
As the world tries to get back to some semblance of normalcy after the coronavirus pandemic, pharmaceutical, biotech and med device companies are anticipating the day when the FDA returns to normal...
Clinical Research Solutions
FDA Guidance on Gene Therapy Products: RCR Testing and Monitoring
Gene therapy holds the promise of curing severe genetic diseases at the genetic level rather than merely treating the symptoms as is accomplished using conventional small-molecule drug therapies. In...
Clinical Research Solutions
How to Prepare for the Three Type B Meetings with the FDA
The Food and Drug Administration (FDA) has laid out a drug development continuum that includes three milestones, or Type B meetings. Earliest is the Pre-IND meeting, the second is the End of Phase 2...
Clinical Research Solutions
How to Understand and Avoid Common Phase 3 Failure Points
By the time the drug development process gets to Phase 3, it seems reasonable to assume that the chance of failure is relatively low. After all, the entire early-development process is at least...
Clinical Research Solutions
The Unique Challenges of Gaining Approval for Drug-Device Combos
A combination product is composed of any combination of a drug and a device; a biological product and a device, a drug and a biological product, or a drug, device, and a biological product. Consider...
Clinical Research Solutions
Analytical Methods for the Investigation of Carcinogenic Nitrosamines in APIs and Drug Products
Since September 26, 2019, all EU Marketing Authorization Holders (MAHs) of medicines for human use are facing what might be regarded as a new requirement: review their drug products on the possible...
Clinical Research Solutions
Why is Process Optimization so Important in Cell and Gene Therapy Product Development?
A recent survey of experts from 145 cell and gene therapy (CAGT) companies revealed the ability to appropriately optimize the manufacturing process as their top concern. Red flags have been raised...
Clinical Research Solutions
2020 in Review: Reflecting on the Biggest Events & Breakthroughs
2020 has been an unusual year. You could also describe this year as different, difficult, and challenging, just to list a few – the list could go on for days. And yet, this year leaves us with...
Clinical Research Solutions
Improve Quality Using an Organizational Maturity Model
If this is your first introduction to an Organizational Maturity Model (OMM), you may have a few questions. What is an OMM? What are some common obstacles I might face when implementing an OMM? How...