Ocular Therapeutix™ adopts BSI’s CTMS software for its Ophthalmology clinical trials

With a number of recruiting and soon-to-be recruiting trials and more than 30 completed studies, in early 2023 Ocular Therapeutix knew it needed a state-of-the-art solution to optimize its clinical operations. “When our team first saw a demo of BSI CTMS, we were very much impressed by the software’s comprehensiveness and immediately recognized the potential in streamlining our day-to-day workflows,” said Alet van Beek, Head of Clinical Operations at Ocular Therapeutix. BSI’s eClinical system allows for the preparation and execution of countless clinical studies in parallel, from site selection to milestone tracking, from monitoring to trial master file maintenance.

“With product candidates in different stages of development and across several therapeutic areas in Ophthalmology, it was critical for us to find a flexible platform that could support the requirements of any trial protocol, regardless of its design, and thus help accelerate time-to-market,” continued van Beek.

As BSI Life Sciences’ Project Manager Cecilia Ferrari explains, the CTMS software “tailors to the needs of virtually any clinical trial, be it of medicinal products or medical devices, and accomplishes this mainly thanks to its no-code configuration capabilities.” In other words, administrators at the client-end can easily apply changes by themselves, without needing to raise a ticket.

Being a company centered around its staff and the patient community it serves, Ocular Therapeutix also puts a strong emphasis on building a collaborative culture with the aim to transform the current standard of care in Ophthalmology: “We value each employee’s commitment to our mission of enhancing the ophthalmic patient experience,” commented Betsy Gillick, Director of Clinical Operations at Ocular Therapeutix. “BSI CTMS with an integrated eTMF (electronic Trial Master File) empowers us with the agility necessary to address specific therapeutic needs, including the leading cause of blindness. At the same time, it encourages cross-functional collaboration by allowing everyone on the same platform. We couldn’t be happier with our choice of this eClinical system.”

Ocular Therapeutix went live with the latest version of BSI’s CTMS in October 2023, following an onboarding process including a requirements workshop and custom training sessions for both administrators and end users. For BSI’s Community Manager of Life Sciences Jan Nielsen, the biopharma’s decision to adopt the software is “great proof of the versatility of our digital solution, which caters well to Sponsors and Vendors leading any type of clinical studies, with the potential to address unmet treatment needs.” Further, the relationship with the Massachusetts-based company is set to strengthen BSI’s market presence in the US: “We’re grateful to Ocular Therapeutix for trusting our eClinical platform and are confident this account will attract other interested biopharmas in New England and beyond,” continued Nielsen. “We look forward to another year of collaboration and mutual success.”

About Ocular Therapeutix

Ocular Therapeutix (NASDAQ: OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, Elutyx™. The company has an FDA-approved, commercially available drug to treat post-operative ocular inflammation and pain and for the treatment of ocular itching associated with allergic conjunctivitis, DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg, for intracanicular use. Ocular Therapeutix has also built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space. For more information, please visit: www.ocutx.com