London, UK -March 2nd, 2022 - Generis, the world's leading provider of cloud-based content and regulatory information management solutions, today announced that the ambitious German biotech company Affimed has selected its CARA™ Life Science Platform to support its clinical R&D teams in the management of Trial Master Files.
Affimed is a fast-growing clinical-stage immuno-oncology company based in Heidelberg, Germany, which is on a mission to transform cancer treatment, harnessing the innate immune system. It is developing pioneering therapies which redirect innate cells to recognise, pinpoint and kill tumour cells.
The company has selected the CARA™ platform to support its clinical R&D teams in the product development, beginning with electronic trial master file (eTMF) management, which will go live in Q2 2022.
CARA offers content and data management solutions for Regulatory Information Management (RIM), Labelling, Quality Management (QMS), Standard Operating Procedure (SOP) and learning management in subsequent rollout phases. CARA can thereby serve as a single platform underpinning all of the company’s R&D workflow.
“The CARA platform from Generis offers us unique potential to enter information and re-use it across the enterprise, without duplication of effort,” said Marc Magdsack, Vice President IT at Affimed. “It connects teams right across the enterprise, supporting a level of insight and collaboration that simply would not be possible if each function had its own separate system.”
As well as optimising business processes, CARA’s capabilities will support automated document creation, management of complex structured content and reports, and analytics.
"CARA will set us up for a whole range of powerful functionality and knowledge insights which will help drive our efficiency forward at pace," Marc commented.
“We feel in very safe hands too,” he added. “This was a complex selection process but from day one we established great rapport with the people at Generis who clearly know exactly what we want to achieve, and share our vision. The expertise of the consulting team was immediately apparent and has given us great confidence and trust, boding well for a successful future together.”
Commenting on the new partnership with Affimed, James Kelleher, CEO and founder of Generis, said, “We’re delighted to be working with a company with great drive and ambition, which wants to get its processes right from the start. It’s exciting to meet a team which shares our vision to avoid or eliminate the information silos of old, enabling accelerated speed to market with next-generation life science innovation, while in confident control of the steadily-growing regulatory and data compliance requirements. We warmly welcome Affimed as an exciting new member of the CARA community.”
Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The company’s proprietary ROCK® platform enables a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors, enabling a broad pipeline of wholly-owned and partnered single agent and combination therapy programs. The ROCK® platform predictably generates customized innate cell engager (ICE®) molecules, which use patients’ immune cells to destroy tumor cells. This innovative approach enabled Affimed to become the first company with a clinical-stage ICE®. Headquartered in Heidelberg, Germany, with offices in New York, NY, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by a bold vision to stop cancer from ever derailing patients’ lives. For more about the company’s people, pipeline and partners, please visit: www.affimed.com.
Generis is a UK-headquartered developer of world-class Content and Data Management technology for regulated industries globally.
60% of the top 20 life sciences companies rely on Generis’ flagship CARA™ Life Science Platform for critical document and information management, including AbbVie, AstraZeneca, Biogen, Gilead, Bayer, Pfizer, and Merck KGaA.
Today Generis serves more than 600,000 users worldwide, across use cases ranging from RIM, Regulatory / R&D and Safety use cases to Clinical, Non-clinical, Quality GxP, CMC, Pharmacovigilance, Medical Information / Medical Affairs applications and more. More at generiscorp.com
Press contact for Generis
Carina Birt, Sarum PR
+44 7970 006624