Consulting Services
We offer end-to-end clinical trial monitoring and site management services, spanning from site feasibility assessments to final closeout, in order to deliver adaptable and exceptionally cost-effective support to our clients throughout their clinical trials.
Proficient clinical operations team comprises highly seasoned clinical project managers with extensive expertise spanning various therapeutic areas, with a specialization in early-phase trials. We offer tailored support to our clients at every stage of their trials, ranging from protocol development to the delivery of clinical study reports.
Our team excels in study start-up activities, including site feasibility assessments, protocol reviews, ethics submissions, and expert guidance on the operational and technical aspects of clinical studies. We are fully capable of overseeing and managing clinical trials from initiation to completion.
Furthermore, our clinical monitoring team leverages a vast network of Proficient staff and trusted Clinical Research Associates (CRAs) across numerous countries. These professionals are highly qualified and possess extensive experience in clinical research and various therapeutic areas, covering all phases of studies.
Our team is well-versed in working as part of larger clinical teams, often involving multiple service providers and vendors. Additionally, we have substantial experience 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
- Consultation on protocol design in the operational perspective.
- Upfront discussion on risks and challenges expected and recommendation / implementation of capa.
- Creation of study-specific documents, worksheets and tools for use by the site and study team.
- Recommendation and identification of facility(ies) or site(s) for healthy volunteers or a specific patient population.
- Collection of essential documents.
- Site initiation.
- Study-specific document distribution.
- Training of site and study team on protocol and study activities.
- Essential document management.
- Document amendments and its management.