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CRD TEAM

Early Phase Clinical Trials

Human Pharmacology studies vis-à-vis Early Phase Clinical trials are essential to identify characteristics of an investigational drugin the early stages of development and to plan an appropriate development based on the drug's profile. Initial phase 1 clinical trials provide an early evaluation of short-term safety and tolerability and can provide pharmacodynamics and pharmacokinetics information needed to choose a suitable dosage range and administration schedule for initial therapeutic exploratory trial studies.

Phase 1 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 1 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

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 formulation
  • Absolute bioavailability (only possible if an intravenous formulation can be given)
Veeda can offer comprehensive advice on Clinical development based on the therapeutic exploratory trails indication under evaluation and the targeted markets to submit.

Other Experimental Medicine Study(IES) Capabilities

  • Glucose Clamp and QTc Studies
  • Drug-Drug Interaction Studies

Clinical Trial Experience in Healthy Volunteer studies - Phase 1 and BA/BE

Veeda is a pioneer in Bioavailability/Bioequivalence studies and has the expertise needed in a CRO partner to ensure the quality conduct of the study. We have completed over 2240+ studies including over 400 bio-studies for major pharmaceutical companies worldwide. Due to a vast and diverse volunteer pool, Veeda can offer rapid turn-around-time for study initiation, decreased lead phase for study commencement after DCGI NOC obtainment, ability to handle Generics, Phase 1 clinical trials, mixed gender studies and Patient studies.
In addition to routine BA/BE studies, Veeda has performed various specialised studies in different therapeutic segments like Inhalation, Nasal Spray, Suppositories, Biosimilars – GCSF, Glucose Clamp and Patches, few of these are highlighted below.
Clinical Infrastructure – Vedant Facility
Inhalation Studies
Recruited 460 subjects in 3 PK & 1 PD trial
Benefits of Dosing in a negative pressure room
  • Uniform environment with consistent temperature, humidity, airflow & oxygen content
  • Eliminates cross contamination
  • Better regulatory acceptance
Patch Study
Performed 5 PK Endpoint & Adhesion Trials on 212 subjects
Glucose Clamp Studies
Performed 11 Studies with 750 clamps of different duration on 296 subjects with Euglycaemic & Hyperglycaemic conditions

Phase 1 Experience

Phase 1 clinical trials start with the initial administration of an investigational new drug into humans. Veeda offers comprehensive advice on Clinical development based on the Therapeutic Indication under evaluation and the targeted markets to submit.
Veeda is one of the few CROs in India who has dedicated Phase 1 unit with state of the art infrastructure and has successfully completed below NCE studies.
  • 4 SAD studies targeted for patients of CKD, thrombolysis, T2DM
  • 5 MAD studies including patients of T2DM and HT
  • 2 Drug-drug interaction studies
  • 3 Food effect studies: targeted for T2DM and HT
  • 2 BA studies with patients of HT
  • 1 repeat dose study with vaccine for immunogenicity and PK
  • 1 Glucose clamp study with NCE including patients of metabolic syndrome

Subject Safety

Subject and Patient safety is of utmost importance for Veeda and we take all measure in terms of infrastructure and resources to ensure the same.
  • Well-equipped and maintained special care area – to handle medical emergency there is provisions of cardiac monitor, defibrillator, ECG machine, suction machine, oxygen cylinder and handy kits like Cardiac Arrest Kit and Anaphylaxis Kit.
  • In-house ambulance – in case of shifting the volunteers to the higher center, an ambulance with basic emergency medicine and equipment is readily available.
  • Stature lift – to rapidly shift volunteer to the ambulance, proper stature lift with generator back up is available.
  • Special set up – facility has all-in-one resuscitation establishment such as Resuscitation Trolley, having all necessary medicines and equipment which can be moved at any area of the clinic to handle medical emergency.
  • Fire and chemical hazard systems – facility has proper equipment and SOP to overcome any fire or chemical hazards as it can indirectly affect volunteer safety.

Safety Team and Safety aspects

  • Qualified, educated and trained study staff
  • ACLS, BLS trained Investigators, Clinical Research physician and Nursing staff
  • BLS trained Phlebotomist ,Clinical custodian, security and Clinical Quality Monitor team
  • Designated Resuscitation officer
  • Well-equipped Special Care to handle the emergency
  • Tertiary care contract with sterling hospital
  • Ambulance and driver 24 hours available
  • Emergency mock drill performs every six month from each clinic to sterling hospital. In both peak and non-peak hours.
  • In peak hours’ time taken to reach sterling hospital was 10 minutes and non-peak hours’ time taken to reach sterling hospital was 8 min.
  • ACLS and BLS refreshing training to each staff member every quarterly.
  • Resuscitation trolley contain oxygen cylinder, cardiac monitor, ambu bag, laryngeal mask, pressure infusoir, cloth stretcher.

WHY PARTNER WITH VEEDA?

  • Veeda is an Independent CRO with 14 years of experience.
  • Veeda has conducted over 2400+ studies for USFDA/MHRA/EU
  • Veeda has over 900+ healthcare professional
  • Veeda has worked with over 200 pharmaceutical companies around the world ,and has Master Service Agreements with many of the top global pharmaceutical companies
  • Veeda has been audited 17 times since 2016 by the USFDA and has had no 483
  • We have over 600+ analytical methods
  • Quality is part of our DNA.

Our exemplary regulatory track record

USFDA
33 times
Brazil ANVISA
7 times
WHO
5 times
UK MHRA
3 times
EU - AGES
1 times
South Africa - MCC
1 times
NPRA - Malaysia
4 times
DCGI
13 times