Clinical Research Solutions
6 Ways Data Science Can Improve Your Life Sciences Operations
The proper use of data science and predictive analytics can improve any online business, in or out of the medical field, but plays a particularly unique role in the life sciences. Science seeks truth...
Quality & Compliance
United in Diversity: Six Tips for European Batch Release
Europe consists of 44 countries, and 21 supranational organizations and within the EU alone there are 24 official languages. So, how do you navigate the differences across Europe in the EU? And more...
Clinical Research Solutions
Deep Dive: FDA Guidance on Gene Therapy Products: RCR Testing and Monitoring
In January 2020, FDA published a guidance document entitled “Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient...
Clinical Research Solutions
Best Practices to Reduce Impurities in Generics
Recent recalls of dozens of lots of the front-line blood pressure and heart medications including valsartan, losartan, and irbesartan are placing the spotlight on impurities in generic drugs. After...
Enhancing CRO Capabilities with Independent Physician Services
The involvement of Medical Monitoring (MM) and Data Safety Monitoring Boards (DSMB) in trials has been somewhat unknown to individuals outside of clinical circles. That is, until media attention...
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
What is Software Quality Assurance (SQA) and Do You Need it For Your Business?
If your only method of quality assurance is software testing, you're wasting valuable time and resources. Software Quality Assurance (SQA) is integrated into your software development life cycle to...
Clinical Research Solutions
Understanding Responsible Person and Wholesaler Dealers Authorization
Wholesaling is a key factor for drug manufactures and Marketing Authorization Holders (MAH) to ensure supply of pharmaceutical products to their customers at pharmacies and hospitals. Wholesaling of...
Clinical Research Solutions
Project Management and a Successful Reduction in Investigations Backlog: The Beauty and the Beast
Many of us have been faced with this beast that needs taming: a regulatory agency has conducted an inspection of your facility. Their observation is that the backlog of investigations at your site is...
Clinical Research Solutions
5 Steps to CMO Identification and Selection for Cell and Gene Therapies
After assuring clinical validity, finding and managing the right contract manufacturing organizations (CMOs)/contract development manufacturing organizations (CDMOs) is a Sponsor's major concern when...
The Quality of Your Medical Writing Matters (And Here’s Why)
Medical writers need to meet a few critical criteria before they publish their work. First and foremost, people want to see accuracy and explicit knowledge of the field when they’re seeking out...
Top Challenges in Managing Your Product Quality Complaint Lifecycle
The Product Quality Complaint program is an essential tool in a company’s quality and compliance toolkit, not only for reducing patient risk and enhancing customer satisfaction, but because it...
Clinical Research Solutions
The Importance of Using a Multidisciplinary Approach in Early-Stage Development for Cell and Gene Therapy Products
Implementing a multidisciplinary approach in cell and gene therapy product development is critical to the product’s eventual success or failure. In our experience, the consequence of not effectively...
Phase Appropriate Controls and GMPs in Cell and Gene Therapy
How much is too little versus too much when developing quality systems and controls for investigational cell and gene therapies? Because these therapies are being administered to patients during all...
Clinical Research Solutions
Research and Development is More Important Than You Think
Research and development is a key component in the successful discovery and development of new drugs and medical devices entering the market. It’s also an area of big business, with investments in...
Clinical Research Solutions
Brexit: New Regulatory Opportunities in the United Kingdom
As the dust settles on the final Brexit deal, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is forging new opportunities to innovate, increasing its efficiency, and...