Clinical Monitoring Services
Effective clinical monitoring is essential to a successful trial and expediting a drug’s successful launch onto the market. Setting up the first site in a trial is a major milestone but the last site is just as important, maximizing the potential for patient recruitment. Our highly trained, expert and safety-oriented clinical research professionals provide clinical trial monitoring services that are tailor-made to your protocol. Working together with site management and study physician support, the clinical monitoring team embodies Ergomed’s patient-centric approach to help you navigate all stages of a clinical trial. Our clinical trial monitoring team has a minimum of an undergraduate degree in life science or equivalent education and experience, and an average of four years of clinical research experience, with experience across all phases of trials.
The experts in our clinical trial monitoring team support:
- Site identification and selection, performing on-site or remote pre-study visits
- On-site or remote site initiation, interim and close-out monitoring visit activities
- Verification that the rights and wellbeing of clinical study’s participants are protected
- Monitoring to confirm consent, eligibility, safety and data integrity
- Training of investigational site staff
- Informed consent/document translation, verification and back-translation
- Preparation of regulatory or ethics/review board submissions
- Timely submission of protocol/consent and other documents
- The storage of drugs, management of intellectual property and clinical study materials
- Reporting of protocol deviations
- Regular reporting.