Under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP), sponsors have extensive responsibilities for ensuring not only the ethical and scientific quality of clinical trials, but also the...
First produced in June 1996, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) is an internationally agreed standard that ensures ethical and scientific quality in designing, recording and...
Also called Endpoint Adjudication Committees, Clinical Endpoint Committees (CECs) are an increasingly common component of drug development and medical device evaluation. A CEC is a centralized decision-making body for safety and efficacy endpoints. The goal of a CEC is to...
The overarching goal of the Special Protocol Assessment Draft Guidance for Industry May 2016 (HHS, FDA, CDER, & CBER) is to improve the quality of new drug applications (NDAs) and biologic license applications (BLAs) by providing more certainty in the clinical protocol...
Psoriasis is a dermatological disorder that is often paired with underlying systemic disease and multiple comorbidities. While a common condition, its wide range of severity and causes, along with several clinical subtypes, make it challenging to treat. Global Impact of...
Dealing with difficult situations is part of the job for project managers in any field, but clinical project managers (CPMs) must overcome a number of unique obstacles on the way to successful study completion. Read on for some of the...
When selecting a CRO partner, sponsors usually focus on organizational experience – how long the company has been in business, its areas of therapeutic expertise and the breadth and depth of its service offerings. But, sponsors sometimes forget to ask...
Quality and effective risk management are vital to every clinical trial, and their importance is greater still when working in rare indications. Your patient population is small, vulnerable, and geographically dispersed, so there’s limited data and little opportunity to replicate...
A significant part of the FDA’s charge is ensuring the safety of drugs available to the public. While a substantial part of the FDA’s efforts in guaranteeing public safety go into the safety assessment process during drug development, the process...
Thanks for visiting the newest addition to our website, our Premier Perspectives blog! Our goal? To give Premier People the chance to share and discuss their industry insights and ideas with customers, colleagues, patients, employees, and basically, anyone who's interested...