When looking for an eTMF to support STALICLA’s expanding pipeline for neurodevelopment disorders, Head of Clinical Operations Dr. Eric Painbeni had clear goals in mind: the eTMF solution should be easy to use, fast to roll out and affordable for a rapidly growing biopharmaceutical company. ‘When we first heard of BSI Life Sciences, we quickly realized that the product they were offering was perfectly tailored for STALICLA. BSI eTMF doesn’t require a team of IT specialists on the client’s end and can be easily maintained by a Clinical Trial Manager’, said Dr. Painbeni.
STALICLA’s Drug Development Unit based in Geneva, Switzerland, opted for the standard BSI eTMF configuration, which comes with a pre-defined set of modules and utilizes the industry-standard DIA TMF Reference Model. ‘I was very impressed by how fast and smooth the process was. After a 1.5-day introductory workshop I already felt confident using the system. The team at BSI also showed a lot of flexibility when we asked them to configure a couple more user roles on top of the standard set-up we purchased’, continued Dr. Painbeni.
For Jan Nielsen, Community Manager Life Sciences at BSI, the successful rollout at STALICLA should pave the way for the implementation of the BSI eTMF standard solution at other startups and SMEs: ‘The smooth onboarding of STALICLA proves that electronic trial master files are not just for Big Pharma, but for small and medium size organizations too. At BSI Life Sciences we strive to tailor our digital solutions to our customers to make sure they can achieve their research goals, regardless of the scale of their operations’. Mr. Nielsen also added, ‘We are honored to work with a Swiss clinical biopharmaceutical company and look forward to continuing our partnership with Dr. Painbeni’s team’.
STALICLA’s Drug Development Unit based in Geneva, Switzerland, opted for the standard BSI eTMF configuration, which comes with a pre-defined set of modules and utilizes the industry-standard DIA TMF Reference Model. ‘I was very impressed by how fast and smooth the process was. After a 1.5-day introductory workshop I already felt confident using the system. The team at BSI also showed a lot of flexibility when we asked them to configure a couple more user roles on top of the standard set-up we purchased’, continued Dr. Painbeni.
For Jan Nielsen, Community Manager Life Sciences at BSI, the successful rollout at STALICLA should pave the way for the implementation of the BSI eTMF standard solution at other startups and SMEs: ‘The smooth onboarding of STALICLA proves that electronic trial master files are not just for Big Pharma, but for small and medium size organizations too. At BSI Life Sciences we strive to tailor our digital solutions to our customers to make sure they can achieve their research goals, regardless of the scale of their operations’. Mr. Nielsen also added, ‘We are honored to work with a Swiss clinical biopharmaceutical company and look forward to continuing our partnership with Dr. Painbeni’s team’.
