Preclinical Development Services

Virtual Head of and/or Strategic Consulting in the areas of Development, PK/PD, Toxicology, Chemical Development, CMC/Regulatory, Outsourcing, and Clinical Development Planning

IDSC is a fully integrated drug discovery and preclinical development solution. As such, our experts provide clients with the broad range of expertise and services needed to advance their drug candidates to IND. IDSC services in Preclinical Development span the fields of Pharmacokinetics/ADME, Drug Safety/Toxicology/Veterinary Pathology, Chemical Development/CMC, Clinical Program Design, and Regulatory. There are many companies that provide expertise in one area of the process but few that offer the critical integration. The differentiating factor provided by IDSC is the ability to understand and coordinate each discipline (business and technical) to create an integrated plan that is aligned with the needs of the client. IDSC brings these resources together in a collaborative environment to implement an effective strategy from candidate identification to IND filing.

Pharmacokinetics

IDSC scientists bring the expertise needed to evaluate the pharmacokinetic ADME profiles of potential clinical candidates, optimize drug delivery and progress a drug candidate to IND.

Services include:

  • Pharmacokinetic ADME Profile
    • Design and outsourcing of in vitro and in vivo experiments to estimate:
      • Extent of absorption
      • Elimination half-life
      • Bioavailability
      • Protein binding
      • Blood-brain barrier permeability
      • Potential of metabolism or transporter related drug-drug interaction and polymorphism
  • Pharmacokinetic/pharmacodynamic (PK/PD) modeling and human PK projection
    • Design and outsourcing of in vitro and in vivo experiments, and PK/PD modeling to estimate efficacy related dose and concentration
    • Use of interspecies scaling as a tool to extrapolate animal PK/PD data to humans to assess safety margin and to project dose range and dose-regimen for human clinical trials
  • Pharmacokinetics (PK), toxicokinetics (TK)
    • PK and TK analysis to determine PK and TK parameters needed for regulatory filing
    • Preparation of regulatory documents for IND (Investigation New Drug) and IB (Investigation Brochure)


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Preclinical Safety

IDSC brings to the table extensive expertise in preclinical safety and pathology to assist clients in progressing their drug candidates to IND.

Services include:

  • Design of toxicology plans and outsourcing of studies for small molecules and macromolecules
  • Preparation of tox summaries and regulatory documents for IND applications
  • Review and safety/pathology assessments for licensing due diligence activities


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Chemical Development/ CMC:

IDSC provides expertise in Chemical Development accumulated by advancing multiple compounds into clinical trials.

Chemical Development services include:

  • Chemical process optimization
    Assess the potential of the discovery synthetic route for producing clinical supplies. Refine the route and optimize yields and minimize safety hazards
  • API outsourcing
  • Pre-formulation and biopharmaceutics strategies
    Begin an early assessment of formulation needs with regards to salt forming potential, polymorph formation, hygroscopicity and chemical stability.
  • Regulatory CMC support includes:
    • Development of regulatory CMC strategies to ensure compliance with regulatory requirements
    • Authoring, coordination and review of CMC sections of investigational & registration dossiers
    • Prepare and represent clients at Regulatory Agency meetings
    • Support and strategy for CMC query/response cycles during agency review
    • Provide regulatory support during Pre-Approval Inspections
    • Electronic Common Technical Document (eCTD) for Quality Modules: training, strategies and policy

Clinical Program Design & Strategy:

An effective clinical strategy, together with appropriate clinical program design is essential for successfully moving a project from candidate identification to IND. IDSC assists clients to produce the right clinical design to address the needs of their program.

Services include:

  • Production of a clinical development plan and protocol development
  • Review of Statistical Analysis Plan (SAP)
  • Interpretation of study results, including review/interpretation of issues arising during conduct of studies
  • Writing of clinical study reports and integration of reports for regulatory submission
  • Interaction with regulatory agencies in support of submissions

Regulatory:

We are your gateway to the FDA and EMEA

We establish a dialogue between the Sponsor and the FDA/EMEA to ensure there is alignment regarding the understanding of the current science and the regulatory requirements. The differentiating factor provided by IDSC is the ability to understand and coordinate each discipline (business and technical) to create an integrated plan that is aligned with the technical realities and the needs of the regulatory authorities. There are many consultants that provide expertise in one area of the process but few that offer the critical integration.

  • We work with client, their staff and consultants to develop, and then implement an efficient and effective global regulatory strategy.
  • Our broad expertise and technical advisory board provides access to experts in all technical areas - clinical, preclinical, chemistry and compliance - to ensure all of the "notes" play a good tune
  • We provide seasoned expertise in managing the regulatory environment.
  • We submit the necessary information in the required format so your development program proceeds on the defined timelines.

We manage your data and information

We manage, protect and maximize the value of your key asset, your data. Electronic information management is not a luxury, it is an expensive necessity.

The regulatory authorities are moving to an electronic environment because they must do more work in a reduced timeframe with reduced resources. The sponsor has the product in development longer than the authorities have it under review; therefore efficiency improvements in the development phase have a larger payoff.

  • We create the documents and reports in the format that is required by the FDA/EMEA.
  • The information is stored in a secure environment where the data are backed up and remotely accessible 24/7.
  • We have a DocumentumTM license and all CTD templates.