Project management
We provide operational management for early stage therapeutic development, from the design of the development plan through
to writing and submission of the clinical trial applications. Some of our clients ask us to manage entire development projects whilst others
prefer to benefit from our services on a punctual basis.
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L2D's dedicated team of experts can:
| 1. |
Design an optimised development plan and timeline specifically tailored to both the product and the client’s business objectives. |
| 2. |
Provide professional and flexible operational project management to ensure efficient implementation of the validated preclinical development plan: |
| • |
Proactively manage the manufacture of the active pharmaceutical ingredient and clinical trial material from contract manufacturing organisation (CMO)
selection and negotiation through to product delivery and report validation. |
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Recommend, negotiate with and validate the most suitable and cost-effective contract research organisations (CROs) for the pharmacology, toxicology, ADME,
pharmacokinetic and pharmacodynamic studies. We coordinate and manage the CROs to ensure timely delivery, with a high quality of service and regulatory compliant reporting. |
| 3. |
Prepare and submit clinical trial applications (IB, IMPD, clinical protocol …) and interact with the Competent Authorities on behalf of our clients. |
We are committed to advancing our clients’ lead therapeutic agents into clinical trials in the most optimal and cost effective manner so that their investment risk is
minimised and the likelihood of product success is maximised.
PROJECT MANAGEMENT
SERVICES |
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CONSULTANCY, STRATEGIC AND
BUSINESS SERVICES |
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Preclinical development plan |
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API manufacturing process development |
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Formulation development |
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GMP manufacture |
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Pharmacology studies |
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Toxicology profile |
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Safety pharmacology package |
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Pharmacokinetics & tissue distribution |
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Analytical and bioanalytical methods |
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ADME |
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Stability & characterisation studies |
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Investigator’s Brochure (IB) |
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Investigational Medicinal Product
Dossier (IMPD) |
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Clinical trial application |
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Strategic planning |
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Drug positioning |
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Strategic advice (target drug profile, competition, Intellectual Property…) |
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Gap analysis |
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Project review |
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Data room construction |
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Interim management |
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In/out-licensing technical evaluations |
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Technical R&D due diligence |
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Select L2D - LeadsToDevelopment - for
your drug development outsourcing requirements - we
deliver non-clinical development expertise to clients who wish to outsource
the management of their preclinical development plan, non-clinical studies
and preclinical evaluation activities.
