Industry group TransCelerate Biopharma has certified that training programs from CROs Icon and SynteractHCR meet minimum criteria for ICH’s good clinical practice (GCP) training.
Both companies’ training programs enable investigators to complete GCP training that is now acceptable for all TransCelerate member companies. Transcelerate’s 19 partner companies include AbbVie , AstraZeneca , GlaxoSmithKline , Johnson & Johnson , Pfizer , Roche and Sanofi .
Non-profit TransCelerate BioPharma’s mission is to collaborate across the global biopharmaceutical R&D community to identify, prioritise, design and facilitate implementation of solutions designed to drive the efficient, effective and high quality delivery of new medicines.
Investigators completing the training will avoid potentially repetitive pre-qualification GCP training for every trial. TransCelerate also has established several clinical data standards, including study site qualification and training.
The industry group also recently launched its clinical trial comparator network , which will establish a reliable means for sourcing drugs to clinical trials.
Icon’s training program, known as Firecrest, offers some unique capabilities that are currently unavailable in other GCP training programs, the company said. Sponsors can assign training requirements to specific job roles, track training compliance and notify users of overdue training or re-certification due dates.
In addition, the program offers enhanced reporting capabilities that allow biopharma companies to analyse and report completion metrics at a region, site or role level.
Steve Cutler, COO of Icon, said the "Firecrest technology platform delivers an innovative suite of training, performance support and study management tools which have proven to enhance the compliance, consistency and execution of study-related activities by study personnel.”
SynteractHCR’s subsidiary European Centre for Clinical Research Training (ECCRT) also has been recognized by TransCelerate.
SynteractHCR said it supports the goal of TransCelerate to enhance focus on qualitative training based on good course design, correct methodology and GCP.
“SynteractHCR and its training facility are dedicated to supporting even higher levels of proficiency in the industry,” said Gerald Van Roey, managing director at ECCRT. “To achieve this end, it was imperative for us to be acknowledged as an industry-recognized site for investigator training. Training is an important investment for companies, and one that will pay off in the long-run, in having both more engaged employees and better patient care.”