@ShahidNShah
Effective clinical monitoring is essential to a successful trial and expediting a drug’s successful launch onto the market
Clinical Surveillance Pharmaceuticals, Biotechnology & Drug Discovery Technologies
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.
Features:
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
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