Generis, creator of the cloud data, content, and business process management platform CARA, today announced that Theramex has selected the CARA™ Life Sciences Platform to digitise and streamline their Regulatory Information Management process.
Theramex, headquartered in London, UK, is a global speciality pharmaceutical company which produce women’s health products and operate in more than 80 countries.
Theramex were searching for a platform to digitise the manual processes across their R&D landscape with a focus on the data and documents within RIM. With frequent audits from regulatory authorities and changing regulations, compliance was a key motivator, alongside a reduction of error and an increase in efficiency across the board.
Steven Niss, Group Information Technology Director at Theramex commented: “We wanted to make sure we selected a partner that is going to be with us for a long time, a dependable partner, with whom we can grow a strong relationship – we believe we can do this with Generis.’
One of the key requirements was full traceability, with teams dispersed globally it is vital to have a safe and a secure way of tracking data, without the risk of something getting lost. The organisation wanted to digitise the manual collection of data and transfer it into a single secure database system, equipped with reporting functionality and the ability to track who did what, and when, to achieve traceability and compliance.
After a selection process with several other vendors, the CARA Life Sciences Platform was selected as it offered rich functionality and was the preferred option for end-users. “From an end-user perspective, the CARA Life Sciences Platform was the most intuitive with a great look and feel, we saw the excellent functionality and with simple configurations the platform was perfectly aligned with our processes.” added Steven.
The CARA Life Sciences Platform gives Theramex the ability to consolidate all processes onto a unified, integrated system. All enterprise data can be stored and accessed on the platform due to its single, structured information lake, eliminating the need for a series of separate point solutions for each process. With the ‘one-user, one-license’ pricing model, and synergy around implementation and project pricing, Generis offered a great solution for a lower overall cost.
About Theramex
Theramex is a global, speciality pharmaceutical company based in London, UK. Operating in over 80 countries, the company are committed to supporting the health needs of women through every stage of life, with products focusing on contraception, fertility, menopause, and osteoporosis. Theramex have helped millions of women around the world live better lives, and continue to work on patient-focused, effective solutions that support women of all ages.
About Generis
Generis is a UK-headquartered developer of world-class data, content and business process management for regulated industries globally. 60% of the top 20 life sciences companies rely on Generis’ flagship CARA™ Life Sciences Platform, including AbbVie, UCB, Biogen, Reckitt, Bristol Myers Squibb, Bayer, Pfizer, and Merck KGaA. Today Generis serves more than 750,000 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