Biology:COMPLi

From HandWiki

COMPLi is a first-of-its kind compliance platform that was launched by Scientist.com in collaboration with the top 25 pharmaceutical companies, contract research organizations (CROs) and biobanks in 2017.1,2

History

As global policies on the provision of biological specimens used for research are not aligned and can be difficult to adhere to for a global pharmaceutical company,  COMPLi was launched in order to improve compliance, oversight and governance through proactive collection of information coupled with bespoke contracts and enhanced compliance tools.3 COMPLi ultimately reduces the administrative burden and inherent risks pharmaceutical companies, biotechs and academic labs face when sourcing regulated services and materials from external third parties.4

In 2018, COMPLi received the Excellence in Pharma: Regulatory and Compliance Framework award at the 2018 CPhI Pharma Awards.5 By 2019, Scientist.com added animal welfare, secondary real-world evidence (RWE), health economics and outcomes research (HEOR), and GxP services to the COMPLi functionality.6 In 2020, Scientist.com partnered with UK biobanks and large pharmaceutical companies to see how COMPLi could help solve challenges biobanks face when working with industry partners.7  Later in 2020, Scientist.com launched the COMPLi HBS Legislation Series, an ongoing educational webinar series intended to inform researchers of the varying regulations governing biological specimen acquisition globally.8,9,10,11 By the end of 2020, Scientist.com expanded COMPLi to include VERIF.i, a supplier pre-assessment program designed with input from multiple large pharmaceutical companies to enable proactive pre-assessments of suppliers in various higher risk areas such as biological specimen provision, animal welfare and Chemistry Manufacturing and Controls (CMC).12

In 2021, Scientist.com partnered with Enhancing Quality in Preclinical Data (EQIPD) to better monitor and enhance the role that preclinical quality certifications can play in fostering biopharma-CRO relationships—through COMPLi, a preclinical service provider can now self-certify against the EQIPD standard and promote this to organizations to increase confidence in the quality of data being generated through