Freelance Clinical Project Manager in the Life Sciences Industry

Identifying new investigators for collaboration in clinical research is extremely important to industry. Each trial is usually part of a programme leading to a product licence application and availability of the medicine to patients. The development of every new medicine is planned carefully, with results from early studies required to decide the dose, frequency and formulation to be used in later studies and ultimately in clinical practice. Delays in a single study can impact on the launch date of the medicine as regulatory applications cannot be submitted until the clinical data is available.

Commercial studies are conducted in a truly global market, with countries having to compete for patient allocations based on country feasibility, past performance and cost. Accurate site feedback at the feasibility stage, including looking realistically at the workload involved and the research sites’ available clinical and data entry resource, is really important to a commercial sponsor.

“The UK is perceived to be very expensive compared to Eastern Europe and Asia; to continue to win studies UK pharma companies have to deliver the promises they make to their international R&D colleagues.”

In many companies the performance of all participating countries is measured and tracked using comparison dashboards with countries on-track marked green –countries not delivering being highlighted in red. This may affect where R&D teams decide to place their next study.

For the UK to stay competitive, start up times need to be swift, so companies need sites that have:

· Time to do the study, at the time the study is planned – including the start-up process

· Resource - including inputting data into case reporting forms (CRF) and resolving data queries quickly

· Access to the correct patients

· Data Quality – Good Clinical Practice compliant, good CRF data, good study documentation maintenance

The Central Submission Process (CSP), with parallel review by the ethics committee, MHRA and the NHS trusts has visibly improved start up times over the last 12 months.

“Many companies are keen to work with new ‘green shoot’ sites identified via the research networks to boost UK recruitment, especially in newer therapy areas.”

This approach also prevents well-known investigators from becoming saturated in research, threatening their ability to meet the studies targets and timelines. New ‘green shoot’ sites identified by research networks help spread the workload across the UK and allow the UK study target to be met effectively: this benefits clinical research in the UK – and also, ultimately, patients.

If you would like further information on working with industry in West Midlands South, please contact Sue Elwell, research manager at your local PCRN office on s.elwell@warwick.ac.uk or phone 02476 575 854