Ergomed’s approach to successful Site Management was established over 15 years ago by the company’s founder who was previously a Principal Investigator himself. Ergomed’s assessment and knowledge of the experience of physicians and nurses, investigator facilities, pharmacy and laboratory services significantly improves the access to and the availability of appropriate patients. Ergomed’s Site Management model is an integrated part of Ergomed’s approach to the management of clinical trials.
With over 300 trained Site Coordinators based at sites across Europe and the MENA region. Ergomed has demonstrated high ‘patient-per-site’ ratios as compared to other CROs. Ergomed’s medically led team provides continuous and ongoing site support thereby achieving enhanced patient recruitment rates whilst maintaining data quality. Early and meticulous site evaluation in the feasibility process is critical in ensuring accelerated recruitment.
SSC support to investigators results in:
- Faster recruitment
- More patients per site
- Enhanced data quality
- More timely data entry
- Fewer data queries
- Better compliance to GCP
Ergomed has successfully rescued complex, under-performing and failing trials across a variety of therapeutic indications. These successes are due to the implementation of our Site Management Model combined with our local knowledge and established relationships with investigators and sites. Ergomed advises on the best country strategies for rapid study set-up and trial execution to deliver a successful turn around of a failing study.
SSCs identified and trained by Ergomed work at the sites in full compliance with ICH GCP and completely independently of our CRAs and PMs; they follow their own SOPs and have separate line management and reporting structure. The Site Management Model has been audited as part of regulatory audits and has been used in clinical studies Ergomed has completed for clients that have resulted in successful product approvals in USA and Europe.
In the example illustrated by the chart above, Ergomed was brought into the study 11 months after it started. It recruited 571 out of a total of 762 patients and facilitated the study finishing five months ahead of schedule.”