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| | | - Medextens-Medalliance Consulting is a clinical Contract Research Organization (CRO):
to plan and conduct clinical Phase I to IV studies. The services provided include:
- Clinical study - Clinical trial:
preliminary analysis, design, planning, implementation, population & sample size, patient selection criteria, endpoints, controls, investigation sites, timing
- Investigator management:
selection, recruitment, contracts, training, coordination, meetings, incentives, problem-solving
- Study documents drafting:
protocols, case report forms (CRF), informed consent forms, investigator brochures, study files
- Study regulatory management:
Application with IRBs, ethics committees, CCPPRBs. Insurance policy management, regulatory applications and liaison.
- Study conduct and monitoring:
Investigation site initiation and closure, field clinical monitor training and management, field clinical/technical support, source data verification, adverse event (AE - SAE) reporting and management, investigative supplies management.
- Quality Assurance (QA) - Good Clinical Practices (GCP) - EN 540:
training, auditing, standard operating procedures (SOP) drafting : on-site or off-site compliance interventions.
- Clinical report:
report writing, review
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