Additional Services

ICON employs a team of experienced and highly qualified experts to provide pharmaceutical and biotechnology companies with an evaluation of the medical and commercial potential of compounds in preclinical or early clinical development.

Consulting

Areas of expertise include monoclonal antibodies, immunodiagnostics, protein therapeutics and small molecules. Our due diligence is based on scientific evaluation of the preclinical profile of the molecule to determine potential for development, analysis of the development plans to assess likelihood of success and identification of critical elements on which to base milestone decisions.

Based on our review and interpretation of the pre-clinical and clinical data we will provide a comprehensive summary and recommendations for future directions for projects and compounds. Our scientific staff provides a focused rationale for clinical and non-clinical activities.

We evaluate each project to position it for optimal marketing through a carefully integrated pre-clinical and clinical development plan.

We provide consultation in a diverse array of areas including:

• Pharmacology
• Bioanalytics
• Pharmacokinetics
• Biomarkers
• Anti-drug antibodies
• Toxicology

We aim to identify and optimise go/no-go decision points to help emerging companies develop a comprehensive approach to development.

Data analysis

As an additional tool guiding the development of pharmaceutical and biologic products, ICON Development Solutions offers pharmacokinetic/pharmacodynamic and statistical data analysis services.  Critical to understanding the behavior of pharmaceuticals and biologics under development, these services are geared to meet the scientific, regulatory, and timeline requirements of our clients.

ICON Development Solutions provides timely preparation and compilation of non-clinical and clinical reports including INDs, NDAs, CANDAs, ANDAs and BLAs intended for regulatory submissions. Manuscript preparation services are also available for publication of pharmacology, pharmacokinetic and pharmacodynamic studies in peer reviewed journals or as tools for dissemination of product information. 

Documents can be prepared for direct submission to regulatory agencies or scientific journals, using in-house or client supplied formats.

PK/PD analysis services include:

• Compartmental, non-compartmental and population pharmacokinetic/pharmacodynamic data analysis to support:
  • Bioequivalence Studies
  • Drug Interaction Trials
  • Disease Effects on Pharmacokinetics (renal, hepatic, diabetes, etc.)
  • Dose Proportionality/Tolerance Studies
  • Allometric Evaluations
  • Pharmacokinetic/Pharmacodynamic modeling of analytical results
• Statistical evaluations of study results