Clinical Research Solutions
How to Avoid Common Pitfalls in the Development of Biosimilars
As many blockbuster biologicals face the expiration of their patents, so-called "patent cliff", many biotech businesses direct their attention to the field of biosimilars. The development of...
Clinical Research Solutions
Why Partner with a CRO that has In-House DCT Capabilities?
When you need to outsource your clinical trials and decentralized visits, it can be beneficial to select a single provider that can do both. There are many synergies that come from using a single...
Clinical Research Solutions
7 Questions to Ask When Selecting a DCT Provider
When considering a decentralized approach to your clinical trial, it can be confusing or overwhelming to identify a provider that will truly understand and support specific study needs. ProPharma...
Clinical Research Solutions
4 Steps to Decentralize Clinical Trials
Decentralized Clinical Trials (DCTs) is a buzzword in the clinical research space that has been gaining notoriety because of the COVID-19 pandemic. It’s a concept that revolves around bringing...
Clinical Research Solutions
FDA's Expedited Programs Explained
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...
Roadmap for Successful IVDR Transition, Part III: Project Management
The compliance dates for the In Vitro Diagnostics Regulation (IVDR) are quickly approaching in May 2022. In this blog series, we discuss the final months before the IVDR date of application, how to...
Why You Need a Decentralized Clinical Trials Strategy - Before Disaster Strikes
Imagine having your clinical trial ready to go, or already underway, and overnight the brakes are slammed, bringing your trial to a screeching halt. This was the reality for sponsors around the world...
What the IVDR Is and How to Prepare
In May 2022, the IVDD will be repealed by the European Committee, thereby ending the transition period. To ensure you're compliant with IVDR by that date, learn everything you need to know about the...
Clinical Research Solutions
Roadmap for Successful IVDR Transition, Part II: Technical Documentation & Software
The compliance dates for the In Vitro Diagnostics Regulation (IVDR) are quickly approaching (May 2022). In this blog series, we discuss the final months before the IVDR date of application along with...
Clinical Research Solutions
FDA’s Breakthrough Therapy Designation vs PRIority MEdicines (PRIME) Application in Europe
What are Breakthrough Therapy Designation and PRIority MEdicines (PRIME) Applications? The advancement of modern medicine, and the accessibility of researched and regulated medication, has greatly...
Clinical Research Solutions
Roadmap for Successful IVDR Transition
Roadmap for Successful IVDR Transition: The compliance dates for the In Vitro Diagnostics Regulation (IVDR) will become effective on May 26, 2022. To help you with the IVDD to IVDR transition, we've...
Clinical Research Solutions
Top Questions & Answers for Managing the New IVDR
With an increased need for high quality in vitro diagnostic medical devices (IVDs), the In Vitro Diagnostic Regulation (IVDR, 2017/746) was entered into force for all IVDs in 2017 with a five-year...
Should You Undergo Virtual Factory Acceptance Testing?
Although domestic travel is slowly ramping up, companies may still consider virtual factory acceptance testing (FAT). FAT is an optional step in the life sciences’ process of purchasing factory...
Regulatory Sciences
Regulatory Strategy for Clinical Trials in the European Union
Setting up a clinical trial in the European Union (EU) has historically been an expensive and time-consuming business. With 27 individual member states each requiring its own review and approval, it...
Regulatory Sciences
Is it Time to Sharpen Your Target Product Profile (TPP)?
Is it Time to Sharpen Your Target Product Profile (TPP)? We’ve heard it countless times: "Fail early and live to fight another day." "Preserve capital, human resources, and energy for a project with...
Clinical Research Solutions
7 Benefits of Working with a Biostatistician
Biostatisticians have become increasingly important as many data-driven public health projects and clinical trials have expanded. So, what exactly does a biostatistician do? These individuals are...