Patient Based Studies

Veeda Clinical Operations department has a dedicated team of 30 experienced professionals in different functionalities of Project Management, Medical Writing, Start-up, and Medical Monitoring. Veeda completed 600 plus feasibility studies for >100 molecules across various Therapeutic areas in the last 3 years with an average of 200 feasibility studies per year.

Our Clinical Operations Experience

As a team, we have completed 30 clinical trials (Phase II, III and Patient BA/BE studies) in the various therapeutic area such as Oncology, Psychiatry, Ophthalmology, Rheumatology, Cardiology, Dermatology, HIV, and bone diseases. The clinical Operations team at Veeda has successfully faced a total of seventeen (17) USFDA inspections at Investigator sites (at which Veeda had conducted PK studies) with no adverse observation.

Veeda Clinical Operations Experience

Veeda Clinical Research has completed 29 patient based clinical studies so far, out of these 23 studies are PK endpoint studies and 6 clinical endpoint studies (4 phase II and 2 phase III). We have enrolled more than 1250 patients in various therapeutic areas and worked with more than 125 sites across India in different therapeutic areas such as Oncology, Psychiatry, Ophthalmology, HIV, Rheumatology, Dermatology and bone diseases.

Organization experience

Completed Projects

  • 26 patient based clinical trials
  • 4 Stand-alone Medical Writing BE-PK studies

Ongoing Projects

  • 8 Ongoing PK studies in different stages of execution
  • 2 Ongoing Clinical endpoint studies in different stages of execution

Team Experience (Previous Organization)

Combined Team Experience in Clinical Trials. More than 130 clinical trials that includes.

  • Around 25 global clinical trials
  • Around 30 clinical endpoint studies
  • 75 patient based PK clinical trials

Investigator’s Database

We have database of more than 600 Investigators sites for which preliminary feasibility evaluation has been done in various therapeutic areas and having capabilities of enrolling patients with following indication with mentioned recruitment rate.

Investigator Database

Therapeutic Area Investigators Database No. of sites associated with Veeda
Oncology 150 Oncologists 90 sites
Psychiatry 90 Psychiatrists 35 sites
Orthopedics and Rhuematology 72 Orthopedics and Rheumatologists 25 sites
Infectious Disease 79 MD Physicians 25 sites
Dermatology 87 Dermatologists 40 sites
Cardiology 20 Cardiologists 35 sites
Ophthalmology 90 Ophthalmologists 40 sites
Urologist 27 Urologists 12 sites
Nephrology 66 Nephrologists 15 sites
Pulmonology 80 Pulmonologists 40 sites
Gastroenterology 45 Gastroenterologists 10 sites
Endocrinology 38 Endocrinologists 20 sites
Hematology 16 Hematologists 15 sites
ENT 35 ENT Specialists 10 sites
Gynaecology-Obs 70 Gynecologists 20 sites

Quality Management System (QMS) at Veeda

Compliance checks
Qualification and experience of study team, and documented relevant training with compliance to Good Clinical Practices (GCP)
Documented approval from the relevant Institutional Review Board (IRB)/Independent Ethic Committee (IEC) prior to start of clinical trial
Availability of all essential documents such as protocol, protocol amendments, study procedure manuals and informed consent forms (in studies that involve patient enrollment)
Complete availability and accuracy of source data per GCP
Close monitoring of clinical trial supplies/equipment’s and investigational medicinal products (IMPs) for calibration/expiration at trial sites
Regular monitoring of trial sites for resource adequacy
Good storage and distribution practices for storage of IMPs and PK samples
Documentation per GCP at each stage of the trial
Reporting of subject adverse events (AEs) and serious adverse events (SAEs) to the IRB, regulatory authorities and Sponsor

Why Partner With Veeda?

  • Independent CRO with 15 year of experience in clinical research.
  • 8 years of patient based Clinical trial experience.
  • Experienced team to handle the criticalities and challenges of the studies.
  • Scalable team approach.
  • Proven track record of timely recruitment completion even for are indications like RCC and SCLC.
  • Database of pre-screened experienced, GCP compliant Investigators with good tested recruiting potential.
  • Worked with more than 125 Investigators sites in different therapeutic areas.
  • Excellent regulatory liaison for obtaining DCGI approval/BE – NOC.

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