Shore Research & Development, LLC provides clinical consulting services and clinical operations expertise to pharmaceutical and biotechnology companies. Our operations solutions focus on timeline management, cost controls, and quality assurance.
CLINICAL OPERATIONS CONSULTANCY
CRO/VENDOR DUE DILIGENCE
Shore Research and Development, LLC works with global clients providing a comprehensive range of clinical operations services, including vendor selection, CRO management, financial analysis, budget negotiation, strategic sourcing and project management for all clinical trial phases.
As small biotech companies transition from preclinical studies to FIH/2a studies, Shore R&D, LLC provides CRO/vendor due diligence to identify a CRO you can view as a partner in development. We do not operate under a preferred partnership basis but rather tailor our solutions to individual client needs.
When client needs fall outside of Clinical Operations we will work with you to provide a solution. Additional sub contracted services include but are not limited to Regulatory Affairs, legal document review, Audits and Inspections.
Shore Research & Development, LLC provides clinical consulting services and clinical operations expertise to pharmaceutical and biotechnology companies. Our operations solutions focus on timeline management, cost controls, and quality assurance. Leveraging industry expertise and following a process for vendor due diligence, we partner with clients in the early stages of clinical development. As research and development partners, we prepare our clients for those critical decisions as they transition through the clinical trial phases.
We focus on two specific elements for the greatest benefit.
A pragmatic approach to vendor partnerships.
We take an unrelenting focus on congruence when identifying vendors for clinical trial services.
Shore R&D, LLC works with clients to determine:
critical services required,
vendors for consideration,
schedule capability presentations,
manage the proposal process,
proposal reviews and reconciliations,
and last provide a recommendation for vendor selection culminating in contract negotiation.
A focus on timelines and cost from the start.
Developmental biotech companies have a required focus on cash burn and for good reason. In order to succeed, compound development cannot afford actual costs that are significantly higher than those proposed.
Change orders stem from two sources:
The first is a change in contract specifications and assumptions following work order signature.
The second source is specifications and assumptions that were not properly
communicated prior to work order signature.
Shore R&D, LLC works with both the client and vendor to ensure that the extent of the services proposed match the exact services required.
It is critical for clinical operations to have clear budget forecasting at the onset followed by timeline and budget management. Shore R&D, LLC works on our clients’ behalf to ensure rapid implementation, study start up, real-time adjustments, and robust performance/metric tracking. We provide management of clinical trial operations with”cradle to grave”expertise.