Case Study

Oracle PaaS eSignature Solution for Braeburn Pharmaceuticals

Customer: Braeburn Pharmaceuticals

Industry: Pharmaceuticals

Business Pain: Global regulatory compliance of pharmaceutical companies has changed rapidly in recent years. This increase in regulatory complexity has increased the burden of compliance for most organizations including direct costs of compliance planning for new regulations, executing those plans, and documenting/defending the execution. Braeburn required a system that would facilitate the communication and acceptance of drug trail participation with minimum effort and the ability to adapt to new drug trials as they arise. They needed a form compliant and approved by the FDA for trail participants that tracked the distribution and acceptance of form and provided detail reports for the FDA.

How we fixed it: TekStream deployed HelloSign’s HelloWorks forms application along with the Oracle Content and Experience Cloud and Oracle Process Cloud Service to construct a RIMS microsite for the facilitation of the common repository, form creation and distribution, and capture of the eSignature process.  This solution is integrated with other key components of the Braeburn infrastructure to ensure the creation, distribution, and capture of key materials while providing the necessary tracking and reporting information for distribution to the FDA.  FDA approved participation forms were created in HelloWorks and distributed to participating Pharmacists, Nurses, Physicians, Nurse Practitioners, Physician Assistants, and other qualified parties.  Braeburn managers utilize the microsite to access and track forms as they are being process.  The forms are built to ensure dynamic re-usability based upon the type of participant showing relevant information and form fields as required by each type of participant.