Boyds' clinical operations team offers comprehensive clinical trial monitoring and site management services from site feasibility through to closeout to provide flexible and highly cost-effective support to our clients with their clinical trials.
Boyds’ clinical monitoring team comprises of an extensive network of Boyds employees and trusted CRAs across a number of countries all of whom are highly qualified, professional and have extensive clinical research and therapeutic area experience across all study phases.
Boyds’ monitors can provide country-specific insights, contacts with Key Opinion Leaders and study site personnel. They also provide direct support to the Boyds Regulatory team with the ability to liaise with local regulatory agencies and associated committees in their countries.
From study start-up activities, including site selection and reviewing clinical trial protocols, to handling ethics submissions and providing advice on operational and technical aspects of clinical studies, the team is able to oversee and manage clinical trials from start to finish.
The team regularly participates as part of larger clinical teams, involving multiple service providers, and is also experienced in human challenge studies.
Our services at a glance:
- Strategic Protocol review
- Site identification and feasibility assessments
- Site qualification and initiation
- Site budget and contract negotiations
- Management and facilitation of IRB/IEC submissions
- Generation of study documents, including patient-facing documents
- Systems user acceptance testing
- Consultation on monitoring strategy/generation of Monitoring Plan
- Instream site monitoring and management including ePRO and EDC
- Centralised/remote monitoring
- ISF management including regulatory document collection and review
- eTMF review and oversight
- Site closeout
- Clinical trial vendor selection and management