• Clinical Development plan and strategies
  • Planning for early stage clinical development programs
  • Medical, regulatory and scientific writing (IB, protocol, manuscripts etc.)
  • Quantitative Pharmacology - Pharmacokinetics (PK) and Pharmacodynamics (PD)
  • Clinical and regulatory support
  • Advice on plan, design and execution of nutraceutical products

Clinical PK and PK/PD data analysis and interpretation

ISHA, have highly skilled and experienced clinical pharmacology group for the analysis, and interpretation of PK/PD data. We also provide assessment of clinical relevance and insight into results for use in drug research and development decisions for clients. Our experts bring the experience of drug labeling, integration of populations PK/PD studies into clinical studies to obtain useful safety, efficacy and dosage optimization information to impact drug labeling.

Key services include:
  • Expert PK input to preclinical and clinical development plans
  • Study design with sample size calculation, optimized sampling schedule
  • Drug-Drug Interaction (DDI) assessment
  • PK/PD Analysis - modeling the relationship between exposure and response using nonlinear models and nonlinear mixed
    effect modeling.

Transparency in clinical trials

We at ISHA, provide services, technology, and expertise to meet evolving transparency and disclosure requirements by the sponsors. Our team is highly qualified and experienced in clinical trials development and implementation across various therapeutic areas. They, thus, have impeccable capabilities to provide reliable solution for clinical trials disclosures.

Key services include:
  • Writing simple, easy to understand clinical lay/plain language summaries (CLLS)
  • Review of the CLSS, to authenticate its compliance with the regulations
  • Supports clinical protocol registrations and disclosure of study results