Preclinical Development Support
LEADS TO DEVELOPMENT (L2D) bridges the gap between therapeutic lead identification and clinical development, enabling companies to confidently outsource the management of their preclinical and non-clinical development. Our clients benefit from our development expertise without having to build additional internal headcount, whilst we ensure that their products are advanced rapidly and cost effectively to clinical proof of concept.
How we can help
We offer a personal service carefully tailored to our customers' needs that maintains the transparency, flexibility and availability associated with an internal team. These services include:
- A customised regulatory compliant development plan specifically designed for both the product and the company’s business objectives.
- Management of the manufacture of the active pharmaceutical ingredient and clinical trial material, from contract manufacturing organisation (CMO) selection, negotiation and auditing through to report validation, delivery and distribution.
- Identification, qualification and coordination of the multiple contract research organisations (CROs) required to perform non-clinical pharmacology, toxicology, safety pharmacology, ADME, pharmacokinetic and biodistribution studies.
- Proactive and flexible project management to ensure accelerated project progression.
- Preparation and submission of clinical trial applications (CTAs), including the Investigator’s Brochure (IB), Investigational Medicinal Product Dossier (IMPD), regulatory activities and clinical protocol.
In addition to our operational non-clinical development management, our thorough understanding of the biotechnology sector allows us to offer a range of business and strategic advice and services (including due diligence) to investors, academic groups, biotechs, and pharmas. We provide the expertise required to assess project potential, design development strategies and deliver effective project advancement in order to minimise risk and increase project value.
Our offer to LBIC clients
We offer favourable rates to LBIC clients allowing them to access one of the most rapid approaches for building preclinical value for both their company and its investors.