EARLY CLINICAL DEVELOPMENT SOLUTIONS
"Our company currently has a promising pre-clinical biotech compound, which potentially could be further developed in multiple indications. Our Board would like to see a high level strategic plan describing the various clinical development pathways inclusive valuations, risk assessments and risk mitigation strategies"
"We just finished a successful clinical Proof-of-Concept study and are preparing for license negotiations with a large Pharma company"
"We just initiated our First-in-Human study and would like to further map out our development program."
STRATEGIC ASSET DEVELOPMENT PLANNING

Our cross-functional approach offers clinical, manufacturing, commercial and regulatory insights across all phases of product development, which would allow you to make well-informed strategic decisions. The high-level approach combines expertise and modeling as well as scenario planning tools in order to provide you with range of potential alternatives for decision purposes. 

EARLY CLINICAL DEVELOPMENT SOLUTIONS
"We have a late stage pre-clinical compound for which we would like to initiate a First-In-Human clinical study as quickly as possible."
EARLY CLINICAL DEVELOPMENT SOLUTIONS

Our integrated approach is designed to streamline every aspect of your early stage clinical studies:

 

  • Regulatory requirements (CTA/IND package)

  • IMP operations and strategy

  • Study design

  • Investigative Site identification and patient recruitment

  • Vendor Management (CMO, CRO, Stat, Medical Writing)

  • Clinical Project Management

  • Clinical Quality Management

EARLY CLINICAL DEVELOPMENT SOLUTIONS
"As we're preparing for a phase transition into clinical phase 1 we would also like to align our manufacturing capabilities with current GMP regulations."
"The manufacturing process and related supply chain for our biotechnology product is very complex. How can we optimize the current process also in order to develop a formulation/dosage form appropriate for use in the intended clinical studies".
ADVISORY SOLUTIONS

Built on broad understanding of end-to-end drug development and industry expertise we also strive to offer solutions for specific questions you may have during the life-cycle of your products and programs.

© 2020 by LFSCNC. LFSCNC is the trade name of HDH Consulting BVBA.