Clinical Research Solutions
Lean Principles: A Life Sciences Overview
Today, with the FDA endorsing fewer new treatments, life sciences companies are pressured to develop better therapies while also struggling to control costs and retain their star employees. And while...
Clinical Research Solutions
A Guide to Understanding Long Term Follow-Up for Gene Therapy Clinical Trials
When conducting a clinical trial, there are many aspects sponsors need to be aware of with regards to clinical safety, product efficacy, and the ability to bring treatments through the multiple...
Clinical Research Solutions
How Should You Respond & React When Employees Become Infected with COVID-19?
On Friday, June 19th, the FDA issued a guidance document explaining what manufacturers of drugs and biological products should do, if and when, employees become infected with COVID-19. The...
Clinical Research Solutions
6 Tips for Evaluating Your CMO’s PAI Readiness
The submission of your drug application (NDA, ANDA, BLA, etc.) is an exciting accomplishment, and one of the first major milestones is a pre-approval inspection (PAI) of the manufacturing sites...
Clinical Research Solutions
How Opioid Analgesic Drugs are Approved by the FDA
The benefit-risk assessment is the cornerstone of how all drugs are approved. This assessment captures the scientific evidence, uncertainties, policy, and reasoning used by FDA officials to arrive at...
Clinical Research Solutions
Conducting a PAI Mock Inspection: How to Execute and Evaluate Your Findings
Did you miss our last blog on PAI Readiness? Catch up here to learn what a PAI is and how to prepare. Congratulations! You conducted a Mock Inspection in preparation for your upcoming Pre-Approval...
3 Factors to Consider in the Manufacturing Phase for Drug Device Combination Products
Combination products represent an important and growing category of therapeutic and diagnostic products. They come in several configurations and can be composed of any combination of a drug and a...
Clinical Research Solutions
Pediatric Labeling Best Practices
A large percentage of drugs are used off-label in pediatric patients. Unfortunately, when a patient uses a drug off-label, the drug is being used without FDA approval, which might result in...
Clinical Research Solutions
8 Common QMS Mistakes to Avoid
Previously in part two of this three-part blog series, “Mitigating Compliance Risk with Your Quality Management System,” we discussed how a robust and risk-based Quality Management System (QMS)...
Clinical Research Solutions
Mitigating Compliance Risk with Your Quality Management System
In the first blog of this three-part series, "Overlooking Your QMS Could Cost You," we discussed the cost of "good" versus "poor" quality, and the importance of investing in a "good" Quality...
Clinical Research Solutions
Enterprise Resource Planning (ERP) Systems in the Medical Industry
Drug and medical device development and manufacturing is a complex process that involves multiple supply chains, various monitoring systems, and countless players from R&D to market. Due to the...
Clinical Research Solutions
Medical Device Regulation in the EU in the Midst of the COVID-19 Pandemic
Background: Medical Device Regulation in the EU Unlike device regulation in the U.S., which is governed by the FDA, in Europe, medical devices are not regulated by the EMA. Rather, medical device...
Clinical Research Solutions
Overlooking Your QMS Could Cost You
A Quality Management System (QMS) bridges an organization's individual compliance practices with regulatory requirements. It establishes the infrastructure and oversight requirements for...
Digital Transformation
Improve your R&D Strategy with These 6 Tips
In 2017, R&D investments in the pharmaceutical space reached more than $70 billion, with projected figures of over $200 billion by 2024. Pharma is one of the two sectors with semiconductors that are...
Clinical Research Solutions
FDA Guidance for Non-COVID-19 Related Clinical Trials During the Pandemic
In March 2020, the FDA published a guidance entitled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency - Guidance for Industry, Investigators, and Institutional...
Clinical Research Solutions
FDA Works to Accelerate the Development of COVID-19 Treatments with New Guidance Documents
On Monday, May 11th, the FDA issued two guidance documents regarding the development of products indicated for the treatment and/or prevention of COVID-19. With these documents, the Agency intends to...