EDC Made Intuitive and User-Friendly
Background | FDA Cleared Class III Medical Device For Advanced Wound Care
EO2 Concepts is an advanced wound care technology company. The company develops and commercializes electrochemical low-dose tissue oxygenation and wound monitoring systems. Their flagship product, TransCu O2®, is an FDA cleared Class III medical device intended to treat difficult to heal wounds such as venous leg ulcers, diabetic foot ulcers and pressure ulcers.
Challenge | 21 CFR Part 11 Compliant And Intuitive EDC System
EO2 Concepts was looking for an Electronic Data Capture (EDC) solution to handle their upcoming marketing study with 10 US based sites and 120 initial subjects. They were using a non-validated registry system and paper, thus needed a 21 CFR part 11 compliant system to meet Good Clinical Practice (GCP) requirements.
To allow for additional sites and future studies, EO2 Concepts was looking for a cost-efficient solution. The system had to be flexible to easily be re-used for upcoming studies in their pipeline. The company compared several vendors, including OpenClinica, looking for the best value/cost comparison on the market.
Solution | ClinCapture: Cost-efficient, Intuitive, And Customized EDC System
EO2 Concepts chose ClinCapture amongst several vendors for two main reasons: The cost/benefit comparison with the other EDC systems available on the market and ClinCapture’s flexibility and advanced customization. The medical device company also wanted to keep control of their data, which ClinCapture offers as an cloud-based solution. The support and training packages were the final deciding factors in their decision to contract ClinCapture.
EO2 Concepts was really impressed by the ease-of-use of ClinCapture. “We can very quickly get to any part of the database without drilling down. We are able to set up sites and enter data in very little time.”
Services provided include study build, hosting, training and support. The company was extremely satisfied with the level of customer service, and points out ClinCapture’s excellent team responsiveness at all levels of the organization. They also enjoyed ClinCapture’s pro-active approach of finding alternate solutions to better address their needs.