PolyPid Ltd. is a Phase 3 biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics. PolyPid’s proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with medications, enabling precise delivery of drugs at effective release rates, over durations ranging from several days to months. PolyPid’s lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of sternal and abdominal surgical site infections (SSIs).
PolyPid’s Phase 3 clinical trial was designed as a multi-national and multi-center study. As such, PolyPid was in need of trusted partners and the most advanced Good Clinical Practice approved technology to ensure efficient design and execution of data strategies, as well as guaranteed data accuracy and integrity.
Why Bioforum and Medidata
PolyPid wanted to work alongside partners that both the pharmaceutical industry recognizes, and the regulators accept, to execute high quality clinical trials. And in line with PolyPid’s mission to bring better treatment to patients, they were looking for partners that had experience with Phase 3 trials and were focused on leading advanced data strategies with cutting edge technology to support complex study designs.
Key to the success of the partnership between Bioforum, a data-focused contract research organisation (CRO), and Medidata, the leading technology platform for clinical research, is their shared mission to make innovative transformations to provide an easier toolkit and accessibility to clients’ data, processing, and analytics. Medidata weaves its partners’ business goals into the collective mission of extending greater value and improving outcomes for all sponsors, customers, and patients alike. Having shared goals enables each company to harness the partnership and ensure improved outcomes for sponsors and clients.
“Bioforum and Medidata are dedicated to making a significant impact on people’s health by transforming the conduct of clinical trials for better and faster therapies. By providing innovative high-quality services and platforms run by passionate value-driven professionals, we can together advance our customers’ clinical trials,” shares Amir Malla, CEO and co-founder of Bioforum.
Medidata helps CROs accelerate the digital transformation of clinical trials. Bioforum’s main mission is to make a revolutionary impact in the clinical data management industry, and to provide professional, streamlined, transparent, and enhanced services for its clients. By doing so, Bioforum and Medidata’s aspirations and total outlook for excellence align and share the same vision, enabling both companies to drive new ideas and initiatives for a healthier future.
The Bioforum and Medidata Journey
Bioforum and Medidata have been working together for nearly a decade, with approximately 30 joint projects to date – half of which are ongoing. Bioforum was looking to partner with a trusted software company with a robust, advanced, regulatory-compliant platform to ensure that its clients’ clinical data was in safe hands and could support any type of study design.
“We focus on data, and only data. We pride ourselves for truly partnering with our clients and delivering a successful outcome. We look at data holistically and offer the client the needed visibility into data trends and issues in real time. We don’t compromise on quality, and we are always innovating and striving for improvement. In Medidata, we have found a technology partner that does the same. Medidata is renowned as one of the best companies in terms of technological solutions for clinical trials – we are pleased to have found a company with a proven track record that we could trust,” says Amir Malka, CEO and co-founder of Bioforum.
Bioforum is currently accredited in several Medidata solutions – Rave EDC (Electronic Data Capture), Coder, Custom Functions, RTSM (Randomization and Trial Supply Management) and Imaging. Rave EDC has capabilities well beyond a traditional EDC system, and it is easy to collect and integrate data from both clinical and non-clinical sources. This has enabled Bioforum to manage various unique and complex study requirements without having to use custom programming.
“While the core product remains to be Medidata’s Rave EDC, we see great value in the adoption of the other tools. The fact that Medidata’s products are on one unified platform saves time and effort-intensive activities of multiple system integrations, and also protects data integrity and helps accelerate study timelines,” Amir shares.
Throughout its partnership with Bioforum, Medidata has worked closely with the company’s staff to provide updates, monitor, and oversee issues, and ensure safe end-to-end support. The robustness and flexibility of Medidata’s solutions has been instrumental in helping Bioforum to transform the conduct of clinical trials to improve access to better therapies and provide clients with an innovative, high-quality service. Bioforum is acutely aware of the potential burden that working on a clinical trial can place on a sponsor, and Medidata’s cutting edge technology makes trials easier to manage, improves accessibility and decreases patient burden. The breadth and depth of experience of both companies helps lead clients to new peaks while ensuring a safe and smooth workflow during the whole life cycle of their trials.