A global pharmaceutical company had over 4 active INDs, with more than 20 clinical studies in phase 2 and phase 3 in oncology indications. Full-service CROs were utilized for each program, but after turnover at both the client company and the CROs, a decision was made to reassign the studies to a central, US based staff. This new study allocation lead to a lack of continuity, internally and externally, and the new team was having trouble getting up to speed on the clinical status of the programs. In parallel, a business decision was made to internalize data management operations.
The combination of employee turnover, a new business initiative, and the sheer volume of work created a need for highly skilled professionals to quickly integrate into the team to support their timelines to meet corporate goals.
Initially, BioBridges provided two SAS programmers to lead the data integration and cleaning efforts. The client purchased software (Medidata/RAVE), and the programmers built the clinical databases. BioBridges then engaged a team 6 data managers to liaise with the CROs. Once the data was transferred to the clients’ internal databases, the data mangers performed strategic and operational activities.
The BioBridges team provided the following:
- Data Management services: CRO Management, site communication, listing review, query generation and review
- Database design, build, and user acceptance testing (UAT)
- Import of raw data files into the new databases
- Supervision of database lock activities
Our client met their business and clinical objectives while building the infrastructure to support its projected future growth.