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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 outsourcing.13  Also in 2021, Scientist.com was named one of the top 10 Pharma Compliance Service Companies by Pharma Tech Outlook for its COMPLi and VERIF.i solutions14.

References

  1. Demery, Paul. (7 October 2019). "A New Online Marketplace Service for Biotech Researchers". Digital Commerce 360. Retrieved 20 July 2023.
  2. Fassbender, Melissa. (4 October 2017). "Add to Cart: Online Marketplaces Join Forces to Provide Researchers Instant Access to Biospecimens". OutsourcingPharma, Retrieved 20 July 2023.
  3. "COMPLi: For Regulated Services". (8 January 2019). YouTube. Scientist.com. Retrieved 20 July 2023.
  4. Preci, Sean. (23 April 2018). "The Threat of a Black Market Within the Market: The Hidden Risks of Sourcing Human Biological Samples". Scientist.com. Retrieved 14 July 2023.
  5. "CPhl Announces Pharma Award Winners". (9 October 2018). PharmaExec.com. Retrieved 12 July 2023.
  6. Fassbender, Melissa. (28 October 2019). "Scientist.com Adds Animal Welfare Module to Compliance Solution". OutsourcingPharma. Retrieved 18 July 2023.
  7. "Video: Overcoming Challenges in UK BioBanking Webinar Series Debrief". (29 September 2020). Vimeo. Scientist.com. Retrieved 28 June 2023.
  8. "Video: Navigating Regulations for Sourcing Human Biological Samples in Russia". (17 November 2020). YouTube. Scientist.com. Retrieved 17 July 2023.
  9. "COMPLi HBS Legislation Series: India". (23 January 2021). Scientist.com. Retrieved 15 July 2023.
  10. "Video: COMPLi HBS Legislation Series: Ukraine". (19 May 2021). YouTube. Scientist.com. Retrieved 15 July 2023.
  11. Menikou, Maria. ( 8 June 2020). "COMPLi HBS Legislation Series: France". YouTube. Scientist.com. Retrived 15 July 2023.
  12. Forbes, Kristina. (24 June 2020). "Scientist.com Expands Award-Winning COMPLi Platform to include VERIF.i a Supplier Pre-Assessment Program". Georgia Bio. Retrieved 20 July 2023.
  13. "How Preclinical Quality Certifications Help Foster Biopharma-CRO Partnerships [Webinar]". (2 July 2021). YouTube. Scientist.com. Retrieved 20 July 2023.
  14. "Scientist.com: Guiding Researchers through the Compliance Maze". Pharma Tech Outlook. Retrieved 15 July 2023.
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