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.