Clinical database programming is a critical phase in the clinical trial process responsible for database design and build to capture CRF data. One challenge Sponsors often face is finding quality and cost-efficient resources to complete database programming tasks. With the rising costs of drug and device development (recent studies now estimate it takes approximately $2.6 million USD to bring a new drug to market), clinical trial Sponsors are looking to cut resourcing costs by outsourcing to low-cost countries.
However, database programming requires skilled resources that understand Good Clinical Data Management Practices (GCDMP), local legislation and industry data standards such as CDISC. The database programming has more of a stake in data collection, accuracy and quality and must understand complicated, multisite Phase IV studies with large patient pools as well as single site Phase I studies with small groups of patients. Larger pharmaceutical companies have the resources to take on full time programmers and allocate their time to various projects. These larger companies benefit from the economies of scale of outsourcing mass amounts of programming work, but how can small to mid-size companies, biotechnology and medical device companies properly source this crucial role? And more importantly, how can these Sponsors still ensure quality database programming?
The profile of a clinical database programmer has changed in recent years. They are now expected to have life science degrees and excellent computer and IT skills to bridge the gap between science and informatics. Database programmers are also well trained and informed on CDISC standards to build the relational database as well as various EDC systems for eCRF data collection.
Clinical trial Sponsors and Project Managers may find it challenging to staff database programmers and then effectively deal with peaks and valleys in the workload. On one hand, the DB programmer needs to be an integrated and integral part of the clinical study team, however for smaller pharma and biotech companies they may not require a Full Time Employee (FTE).
Micro FSP: How Does it Work?
CROS NT has developed the “Micro FSP” model to specifically deal with the difficult task of resourcing a role like the Database Programmer. This model can be customized and scaled to the needs of the Sponsor and provide a Database Programmer anywhere from 1 to 5 days a week depending on the current workload needs. This avoids the need to pay for a full time resource and recruitment fees. The Micro FSP model also successfully covers unforeseen absences (sick leave, holidays, etc) while ensuring the resource is fully integrated in the Sponsor’s project.
By outsourcing a particular function like DB programming, a Sponsor can consolidate workload across projects – which can achieve up to 20% in time savings.
Benefits of Micro FSP for Database Programming
- Scalable and customized solution: determine a workload schedule that fits your needs
- Minimum training required and CRO is responsible for most training requirements
- High quality programming deliverables with a cost-efficient pricing model
- DB Programmers trained in CDISC standards and GCDMP
- Control over overhead costs
- Consistent pricing contract
- Lower recruitment costs
- Flexibility: ability to work on-site or remotely