Clinical Research Solutions
How to Select the "Right" CMO Partner
There are many ways in which you can evaluate a Contract Manufacturing Organization (CMO) to identify the best fit for your company's needs. Every company knows timing is critical to success. But...
Clinical Research Solutions
FDA Launches Crackdown on Deceptive Drug Advertising
On September 9, 2025, the US Department of Health and Human Services (HHS) and FDA unveiled a sweeping effort to clamp down on misleading direct-to-consumer (DTC) pharmaceutical advertising. The...
Clinical Research Solutions
FDA to Release CRLs in Real Time: What Does This Mean for Drug Developers?
On September 4, 2025, FDA announced a sweeping policy change: the real-time release of Complete Response Letters (CRLs); a continuation of FDA's July 10, 2025 publication of previously undisclosed...
Clinical Research Solutions
Transparency Requirements and the Requirement for Document Redaction
In an era of increasing scrutiny and demand for transparency in clinical research, the European Union (EU) has taken significant strides to enhance public access to clinical trial data and ensure the...
Clinical Research Solutions
Balancing Efficiency and Quality in High Volume Medical Information Contact Centers
In the pharmaceutical and medical information space, contact centers serve as a vital bridge between healthcare professionals, patients, and the companies that manufacture and distribute...
Clinical Research Solutions
MAH Expertise Across Eastern Europe — and Beyond
Navigating pharmaceutical regulations across multiple countries isn't just about knowing the rules — it's about understanding the rhythm of each market, responding quickly to change, and having the...
Clinical Research Solutions
MLR Submission Checklist: Preparing for Speed and Compliance
Pharmaceutical, biotech, and MedTech companies invest significant time and resources into developing promotional materials, only to face avoidable delays during the Medical, Legal, and Regulatory...
Clinical Research Solutions
Maximizing Clinical Trial Success: Strategic Approaches for Adding EU Member States in CTIS
Strategic Guidance for Expanding Clinical Trials Across EU Member States with CTIS Expanding a clinical trial to additional Member States within the European Union (EU) Clinical Trial Regulation...
Clinical Research Solutions
The Role of CROs in Clinical Research & Clinical Trials
Clinical trials are complex, resource-intensive, and heavily regulated endeavors that span months to years. For many pharmaceutical, biotechnology, and medical device companies, navigating this...
Clinical Research Solutions
FDA Inspection Readiness: Top Observations and How to Avoid a Form 483
For medical device manufacturers, FDA inspections are a critical component of regulatory oversight and quality assurance. Whether part of a routine surveillance program, pre-approval inspection, or...
FSP Solutions
Recruitment Strategies in FSP: Building Agile Teams to Drive Clinical Success
Staffing has become one of the most critical and complex challenges in the success of Functional Service Providers (FSP) within clinical research. Whether you're launching a global Phase III study or...
Clinical Research Solutions
The Moving Regulatory Landscape for Gene Therapy Trials in EU
Submitting a GMO Application for a Clinical Trial with AAV Viral Vectors Navigating the regulatory landscape for clinical trials in the European Union (EU) has become more streamlined with the...
Clinical Research Solutions
Orchestrating Excellence: How ProPharma Bridges Vendors to Deliver Unified, High-Quality Outcomes
Greater Than the Sum of its Parts An introspection on the complexities of ProPharma Medical Information working with clients and their other outside vendors. Drug development is rarely a one-company...
Clinical Research Solutions
European Marketing Authorization Success: The Critical Role of Quality and Compliance
Entering the European market isn't just about gaining marketing authorization — it's about sustaining it. For life sciences companies, success hinges on a robust approach to quality and compliance,...
Clinical Research Solutions
Pros and Cons of Working with a CRO
A Contract Research Organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract...
Clinical Research Solutions
Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guide for Marketing Authorization Holders (MAHs)
In today’s stringent regulatory landscape, the effectiveness of a pharmaceutical company’s pharmacovigilance (PV) system is supported by three key pillars: the Qualified Person for Pharmacovigilance...