Clinical Development Consulting

We have extensive experience in designing efficient and cost-effective development strategies suitable for smaller pharma/biotech companies with constrained resources. We understand the best approaches to getting your product to approval at a cost and on a timescale that your investors and other stakeholders can support.

Our expert project managers offer operational support, risk identification and issue management throughout the delivery of the clinical study.  We offer oversight of start-up activities, site monitoring, data management and biostatistics, quality, pharmacovigilance and all other elements of study execution.​

We understand the challenges of finding the right CRO to deliver your clinical study. Our understanding of this market allows us to help you select a suitable partner. We also have a network of niche providers who can provide specialist services, an approach which can help reduce overall study costs.

We are specialists in Data Management and can guide you in CRF design, database build and use of electronic patient-reported outcomes (ePRO). We know how to find appropriate Interactive Response Technology (IRT) providers to manage enrolment and randomisation and study drug management.

Selecting high-recruiting study sites, with appropriately qualified teams, is critical to successful study delivery. We can support you with the identification, selection and feasibility assessment of sites across North America and Europe. We understand country-specific requirements and know how to minimise site set-up timelines.

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Our medical team can provide or support study medical monitoring. We can set up and manage an Independent Data Monitoring Committee (IDMC) or Data and Safety Monitoring Board (DSMB) and provide medical oversight of the clinical trial data.