Optimum Cra Services Inc – Services

By: Optimumcra  09-12-2011
Keywords: Project Management, Audit Assistance, Clinical Monitoring,

Optimum offers comprehensive services in clinical monitoring and project managements. Our services include the following:

Phase I-IV Monitoring services for clinical studies in adult and pediatric population from site selection to Close-out visits.

On-Site Support: one-on-one assistance to an investigational study site from patient visit procedures, to CRF entries and query resolution, audit assistance preparation, etc.

Project Management Services:

  • Ethics submission (local and central)
  • Development and reviewing process of the following:
    • CRFs, source documents, consent forms
    • Site negotiation for contract and budget
  • Communication, clinical project and monitoring plans
  • Projection and forecasting of clinical activities & researching

SOP Development and Review of Existing Procedures.

Outsource Liaison: Overseeing different vendors involved in global studies.

Training of New Hire CRAs and Implementation of mentoring and evaluation programs.

Territory Profiling and Development Throughout Canada (access to a wide pool of Investigators in various Therapeutic Area).

Drug/Safety & Pharmacy Co-Vigilance Assistance: SAE reconciliation, preparation of CIOMS and IND Safety letters, SAE listings and narrative review.

Keywords: Audit Assistance, Clinical Monitoring, Project Management, Project Managements, Territory Profiling,