Clinical staff is deeply experienced in executing and managing
clinical trials and observational studies faster and with high
quality data deliverables.
Our clinical study teams
understand the importance of performing accurate feasibility benchmarks
to identify the best sites and investigators to meet or exceed our
clients challenging enrolment rates. To accomplish this
we have built a substantial internal database of quality sites over
years of experience and we provide the management, support and guidance
necessary for these sites to excel. Our staff will work
on the ground with the clinical sites to provide quality data oversight
and we will supplement regular on-site visits with remote clinical
monitoring. This results in an efficient management of site
workflow to deliver faster and high data quality. From start-up to
completion, performance is monitored regularly and measured against
contractual timelines and budgets. Our clinical team is full
of driven and cross-functional people with a deep experience in
executing and managing clinical trials in all phases I to IV and
covering most of the main and more complex therapeutic areas.
Qualified CRAs:
- Extensive experience in many therapeutic areas.
- Trained in ICH/GCP Guidelines and internal SOPs.
- Dedicated to a limited number of protocols at a time.
- Well-qualified CRAs.
Our Project Managers:
- Serves as the window person for the client and project team.
- Maintains a client-oriented and can do approach to address issues innovatively and proactively.
- Broad experience in clinical development, over 8 years median experience.
- We develop and renew our PMs knowledge base to offer unique perspectives and insights to our clients.
Services we provide:
- Site feasibility/selection and study initiation.
- Clinical trial planning and design (including risk-mitigation analysis).
- Clinical on-site monitoring.
- Remote and risk-based monitoring.
- Clinical trial and site management.
- Global and local project management.
- Investigators grant management.
- Vendors management.
- Quality control and oversight.