Clinical Trial Management

Cliantha Research Limited is a leading contract research organization providing a full range of clinical development services to small, mid-size and global pharmaceutical, biotech, generic and medical device companies. We offer comprehensive services including Phase II-III clinical trials, feasibility studies, regulatory submissions, attending regulatory meetings, Project management, Site Management, data management and statistics.

The Cliantha clinical trials team provides a global platform. To meet the requirements of our clients, we offer clinical trial services in India, USA, Canada, Europe, South East Asia and South Africa. We have our own teams in India and North America and we operate through strategic relationships with partner CROs in the other regions.

    We Conduct

  • PK studies in patients
  • Biosimilartrials
  • Phase II/III studies
  • Clinical end point trials for bioequivalence assessments
  • Phase IV trials

    Project Management :

    Efficient clinical trial management required focus on many aspects at the same time.

    How are the sites performing?
    Is the trial progressing on time?
    Is the trial within budget?
    What are the anticipated risks?
    Have we covered the risks?

    It requires a great team effort and expertise to ensure that the trial moves as per plan.

    Our highly experienced Project Managers make sure that the progress of the trial is well planned. They have experience working with Monitoring Plans, Data Management Plan, Statistical Analysis Plans and Drug Safety Plans. The team is trained thoroughly to execute the plan. Most importantly, the Project Managers are always prepared with a Risk Mitigation Plan for the myriad of possible roadblocks that occur during a trial.

    • Key Features of our Project Managers:
      • Hands-on experience
      • Therapeutic area experts
      • Driven by Medical team to train and ensure compliance
      • Risk Mitigation strategies in place
      • Successful Track record of completing trials on time and within budget

    Site Management :

    Cliantha has a network of 1500+ GCP trained Investigator sites. With our excellent rapport with Investigators and Key opinion leaders, we bring a high level of expertise into the execution of the studies.

    Our site management services include identifying the best sites for the trial, helping the sites set up the required infrastructure for the studies, assisting them with resources as required and training the sites thoroughly.

    Feasibility Studies :

    Successful project management depends on the correct feasibility assessment. We perform a detailed feasibility study prior to the start of the trial which helps provide an accurate prediction of the timeline, number of sites required and cost of the trial.

    • Cliantha has a 90% track record of completing studies in the agreed timeline.
    • Cliantha has a perfect 100% track record of adhering to the approved budget.

    With our robust feasibility studies, you can rest assured that your studies will complete on time and within budget.

      Therapeutic Areas and Indications :

      • Metastatic Breast Cancer (mBC)
      • Metastatic Colorectal Cancer (mCRC)
      • Solid Tumors
      • Gastrointestinal Stromal tumor
      • Non Small Cell Lung Cancer (NSCLC).
      • Ovarian carcinoma
      • Prostrate Cance
      • Hemato Oncology

      • Acne Vulgaris (mBC)
      • Psoriasis
      • Scabies
      • Atopic Dermatitis
      • Head Lice
      • Actinic keratosis

      • Atrophic Vaginitis (mBC)
      • Bacterial Vaginosis
      • Dysfunctional Uterine Bleeding
      • Infertility treatments
      • IVF

      • Epilepsy
      • Schizophrenia
      • Parkinson’s Disease
      • Major Depressive Disorders

      • Functional Dyspepsia
      • Duodenal Ulcers
      • Ulcerative Colitis
      • Traveler’s Diarrhea

      • Rheumatoid Arthritis
      • Osteoarthritis
      • Pain and wound healing

      • Asthma
      • COPD

      • Cataract
      • Glaucoma
      • Keratoconjunctivitis Sicca

      PK Studies in patients :

      Phase I studies in patients pose special challenges like performing multiple blood draws in patients, sample handling, concomitant medications, adhering to various restrictions and hospitalization for study conduct.

      Being leaders in the conduct of early phase clinical studies brings a passion in our team and an easy understanding of the standard requirements for a successful Phase I study conduct.

      You can be assured that your project rests in the hands of a professional team who are experts at the conduct of PK studies in patients. Close Monitoring of the sites, extensive training of sample handling and management, Special Observation visit to ensure the correct processes are in place at site and detailed manuals and charts for each activity ensure the seamless conduct of the study.

      Cliantha’s team has conducted several PK studies in patients successfully and six of our clinical trial sites have been successfully inspected by the FDA.