CLINICAL
TRIALS

Veeda has a longstanding history of working for Top 10 Global Pharma Companies in their Clinical Development programs for NCEs. We are equipped with the experience and expertise through our Medical Director and the support medical team to offer the following studies.

SN
TYPE OF ASSAY
EXAMPLES
01
Human Pharmacology Studies
– Phase 1 clinical trials
  • Dose Tolerance Studies
  • Single and Multiple dose PK and/or PD studies
  • Drug Interaction Studies
02
Therapeutic Exploratory Studies
– Phase 2 clinical trials
  • Earliest trials of relatively short duration in
    well-defined narrow patient populations,
    using surrogate or pharmacological endpoints
    or clinical measures
  • Dose-response exploration studies
03
Therapeutic Confirmatory Studies
– Phase 3 clinical trials
  • Well controlled studies to establish efficacy
  • Randomized parallel dose-response studies
  • Clinical safety studies
  • Studies of mortality / morbidity outcomes
  • Large simple trials
  • Comparative Studies
EARLY PHASE
CLINICAL TRIALS

Human Pharmacology studies vis-à-vis Early Phase Clinical Trials are very essential to identify characteristics of the investigational medicine in the early stages of development and to plan an appropriate development based on this profile. Initial trials provide an early evaluation of short-term safety and tolerability and can provide pharmacodynamics and pharmacokinetic information needed to choose a suitable dosage range and administration schedule for initial exploratory therapeutic trials. Phase I clinical trials start with the initial administration of an investigational new drug into humans. Studies in this phase of development usually have non-therapeutic objectives and may be conducted in healthy volunteer subjects or certain types of patients, e.g. patients with mild hypertension. Drugs with significant potential toxicity, e.g. cytotoxic drugs, are usually studied in patients.

PHASE I STUDIES TYPICALLY INVOLVE ONE OR A COMBINATION OF THE FOLLOWING ASPECTS:
  • Estimation of Initial Safety and Tolerability
  • Pharmacokinetics
  • Assessment of Pharmacodynamics
  • Early measurement of drug activity

Veeda has decades of experience in conducting these types of Human Pharmacology / Phase I studies through our full-time Group Medical Director – Dr. Maurice Cross.

EXAMPLES OF PHASE 1 STUDIES ON IMPs/NCEs:
  • First-in-Man Studies
  • Tolerability and pharmacokinetics of escalating single doses
  • Tolerability and pharmacokinetics of repeated doses (usually
    given for 12 weeks)
  • Pharmacodynamics of single doses
  • Pharmacodynamics of repeated doses
  • Relative bioavailability of simple solution of drug compared with
    tablet, capsule or other formation
  • Absolute bioavailability (only possible if an intravenous formulation can be given)

Veeda can offer comprehensive advice on Clinical development based on the Therapeutic Indication under evaluation and the targeted markets to submit.

OTHER EXPERIMENTAL MEDICINE STUDIES:
Late PHASE
CLINICAL TRIALS

Veeda offers an unparalleled Clinical trial service spanning over India, Bangladesh. Such an effective coverage of global locations with highest standards of compliance, cost and time-effective conduct of clinical trials is enabled due to Extensive Investigator network, Experienced and Insightful Project Management team, dedicated internal support staff, established mechanisms for Site Management, Training, Regulatory Liaison, Clinical Data Management, Medical Writing and Quality Assurance activities. Due to such an adept and capable approach, Veeda so far has successfully conducted 4 phase II Global Clinical trials and 7 Patient based Pharmacokinetic studies. Currently, our Clinical trial activities range to a total of 13 studies which include Patient-based Pharmacokinetic studies, and Clinical efficacy end point studies for Generic Molecules.

Phase 2 and Phase 3 Clinical Trials include Therapeutic Exploratory Studies and Therapeutic Confirmatory studies with differing objectives and study designs.

Phase 2 Clinical trials have to be conducted with the following objectives: Earliest trials of relatively short duration in well-defined narrow patient populations, using surrogate or pharmacological endpoints or clinical measures and Dose-response exploration studies.

On the other hand, Phase 3 Clinical Trials have to be conducted for the following purposes: Well controlled studies to establish efficacy, Randomized parallel dose-response studies, Clinical safety studies, Studies of mortality / morbidity outcomes, large sample trials and Comparative Studies.

Veeda is committed to provide the late phase clinical trials services with full compliance to International Standards and Regulatory Requirements.

EARLY PHASE
CLINICAL TRIALS
LATE PHASE
CLINICAL TRIALS