13 Apr 2018
Site Management / Study Physicians

Ergomed’s approach to successful Site Management was established over 20 years ago by our 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.

Our Study Site Coordinators 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 turnaround of a failing study.

Study Site Coordinators are 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.

Study Physician Support

Ergomed has established a Study Physician Team – a highly specialised group of MD’s that deal with the supervision of complicated or demanding therapeutic or diagnostic trials/procedures. All of the MDs that are part of the Study Physician Team have extensive previous clinical practice experience as well as experience in clinical research and drug development.

The presence of an experienced clinician on a study site representing the sponsor improves the understanding of the local investigator of the protocol requirements and improves overall compliance. This speeds up recruitment and lowers the dropout rate. Our Study Physician Team has proven to be highly effective in trials with demanding protocols or study procedures, or low recruitment rates and maintenance of high motivation of the principal investigator is of key importance.

Tasks of the Study Physician Team are:

  • Performing study specific site training
  • Representing Sponsor’s clinical interest at the sites
  • Maintaining good medic to medic relationships with the on-site physicians
  • Supporting investigators in appropriate patient selection
  • Encouraging the sites to seek new study subjects – enhances recruitment
  • Shares the most recent experiences from other sites
  • All potential medical issues are addressed swiftly and resolved