Early Phase Clinical Research

"Excelling First-in-Human Clinical Research through dynamics and discipline"

Capabilities


CBCC offers numerous clinical pharmacology studies to assess safety, tolerability and pharmacokinetics (PK) and/or pharmacodynamics (PD) of investigational product. CBCC owns the expertise and qualified staff for following clinical studies

  • First-in-human (FIH) / First-in-man (FIM) Clinical Studies
  • Single Ascending / Escalating Dose (SAD) and Multiple Ascending / Escalating Dose (MAD) Clinical Studies
  • Cardiac Safety Studies / Thorough QT/QTc Studies
  • PK-PD Studies
  • Dose-Response / Concentration-Response Studies
  • PK Studies of Inhaled or Nasal Spray Products for Enteral Absorption Proportion
  • Drug Genotype Interaction Studies / Clinical Pharmacogenomics (PGx) Studies
  • Food Effect Studies
  • Gender Effect Studies
  • ChronokineticsChronodynamics Studies
  • Age Effect Studies
  • Drug-Drug Interaction (DDI) Studies

Clinical Development Strategies


Interpretation of pre-clinical data

  • Identification of the best route of administration and the best formulation for the investigational new drug
  • Identification of the best clinical indication for the investigational product
  • Identification of the potency and limitations of the investigational product

Designing First-in-Human (FIH) Clinical Study and Subsequent Early Phase Studies

  • Derive the dose for FIH Study
  • Assess the risks associated with human exposure of the IP in clinical studies
  • Identification of the potency and limitations of the investigational product
  • Identify FDA accepted clinical outcomes/clinical pharmacometrics measure of disease/damage/toxicity for clinical evaluation during the clinical trial
  • Define Primary and Secondary Objectives of Clinical Study
  • Define Clinical Outcome Measure for assessment of safety, tolerability and pharmacodynamic effects of investigational product
  • Define criteria for safety analysis
  • Define dose-limiting toxicity and procedures of making dose escalation decision for SAD and MAD studies

Design the flow-charts/sequence of various clinical studies required for the product to reach to the market

Support Pre-IND meeting with the FDA and subsequent IND and NDA Submission

Clinical Pharmacology Unit


The Clinical Pharmacology Unit (CPU) for phase 1 encompasses clinical studies of new chemical entities (NCEs), new molecular entities (NMEs), new biological entities (NBAs) and new drug delivery systems (NDDS) based products. The CPU has the subsequent areas and facilities to handle various phase 1 clinical studies.

  • Volunteer’s screening and waiting area
  • Informed consent room
  • Clinical examination room
  • Sample collection room and ECG room
  • Volunteer’s changing room with lockers
  • Housing area
  • Emergency area
  • Dining & Recreation room
  • PK and PD Sample processing laboratory
  • Elevator accommodating stretcher and on-wheel study bed
  • Pharmacy
  • Central sample storage room
  • Archival room

Each bed of CPU is an 'intensive care bed' equipped with a bedside monitor, two oxygen lines and one suction line. Each one is monitored continuously by our clinical staff during the study. Emergency beds are equipped with medical instruments including a defibrillator, CPR and intubation kit, suction machine, nebulizer, medicines and many more.

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