Services

Phase I, II, III Clinical Trials

What is a clinical trial?

A clinical trial is a research study conducted in humans to evaluate medical, surgical, or behavioral intervention(s). This is deemed the primary method for researchers to determine if a new treatment, such as a drug or medical device is safe and effective in people.

The goal of a clinical trial is to answer specific questions regarding new therapies, vaccines, or diagnostic procedures, as well as new ways of utilizing known treatments.

Phase I

Phase I

Dose-ranging on healthy volunteers for safety

Phase II

Phase II

Testing of drug on participants to assess efficacy and side effects

Phase III

Phase III

Testing of drug on participants to assess efficacy, effectiveness, and safety

Phase IV

Phase IV

Post marketing surveillance in public

Types of Clinical Trials

There are several types of clinical trials:

  • Pilot studies
  • Feasibility studies
  • Prevention trials
  • Screening trials
  • Treatment trials
  • Multi-arm multi-stage (MAMS) trials
  • Cohort studies
  • Case control studies
  • Cross sectional studies

Clinical Monitoring and Site Management

We offer oversight and administrative services to monitor the health and efficacy of treatment impacting clinical research study participants. Our clinical monitors execute the monitoring plan outlined by the sponsors and investigators of clinical trials. The number of clinical monitors per project is dependent on the scale and scope of the trial.

Additionally, we provide site management which entails effective site monitoring and extensive communication between the various stakeholders throughout all phases of a clinical trial – study start-up, study conduct and study closure.

Clinical Trial Management

Our clinical trial management services entail assuming responsibility for directing the process of clinical trials by employing effective organizational strategies and reviewing the results, utilizing rigorous clinical procedures.

Additionally, we offer management of internal and external stakeholders, ownership of the clinical trial strategy for execution, participating in regulatory dialogues, and leading high-performing clinical research teams towards common goals.

Project Management

Our project managers provide leadership of clinical research teams to achieve all
project goals within the constraints of scope, time, quality, and budget, while optimizing
the allocation of necessary inputs, and applying them to meet predetermined strategic
objectives of various organizations.

Therapeutic Areas

Cardiovascular
CNS
Dermatology
Infectious Disease
Oncology
Women’s Health
Gastroenterology
Rheumatology
Cardiovascular
Country Duration Phase
US and Global Multi-Year Trial Epidemiology Study
Indication
Valvular Heart Disease
CNS
Country Duration Phase
US and Global Multi-Year Trial 1, 2, 3, 4
Indication
Epilepsy, Schizophrenia, Stroke, Traumatic Brain Injury, Multiple Sclerosis, Autism, Bipolar Depression
Dermatology
Country Duration Phase
US and Global Multi-Year Trial 1, 2, 3
Indication
Atopic Dermatitis
Infectious Disease
Country Duration Phase
US and Global Multi-Year Trial 1, 2, 3
Indication
COVID-19, HIV/AIDS, and Epstein Barr Virus
Oncology
Country Duration Phase
US and Global Multi-Year Trial 1, 2, 3, 4
Indication
Uveal Melanoma, Triple Negative Breast Cancer,
Esophageal Cancer, Metastatic Melanoma, Pancreatic Cancer, Cancer of the Head and Neck
Women’s Health
Country Duration Phase
US and Global Multi-Year Trial 3
Indication
Bacterial Vaginosis, Assisted Reproductive Therapy (ART)
Gastroenterology
Country Duration Phase
US Multi-Year Trial 1 and 2
Indication
Barrett’s Esophagus
Rheumatology
Country Duration Phase
US Multi-Year Trial 1 and 2
Indication
Myositis and Rheumatoid Arthritis