IND Submission Readiness
Business Problem
The client needed to assess and document the business process and data management and governance for Research Documentation in support of a recent Investigational New Drug (IND) application filing. The company identified that the process management, repository, and effectiveness of the current workflows presented numerous areas of inefficiency.
Hawkins Point Solution
Hawkins Point mapped the current business process workflows used to manage the development, collection and curation of research documentation and outputs which supported the client’s pre-clinical research and regulatory compliance to applicable predicate rules. We documented the operational business requirements, mapping of data sources and consumers, and data integrations, including to third party service providers. We also documented data integrations with internal systems and partners supporting research studies, clinical trials, and overall data management for all regulatory compliance activities.
Results
- RecommendationsFor repository to study reports, streamlined collaboration, and collaboration software
- Platform SelectionOf software to provide workflow and artifact repository capabilities
- Risk MitigationAssociated with current state
