Providing 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 operations team comprises highly experienced clinical project managers with deep knowledge across many therapeutic areas, specialising in early phase trials. We provide clients with tailored support at any stage of their trial, all the way through to full clinical project management from protocol generation to clinical study report delivery.
From study start-up activities, including site feasibility and 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.
Our clinical monitoring team leverages an extensive network of Boyds employees and trusted CRAs across a number of countries, all of whom are highly qualified professionals 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.
The team regularly participates as part of larger clinical teams, involving multiple service providers and vendors, and is 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
- Clinical trial management