Clinical Trials Management

Clinical Trials Management

Cliantha Research Limited is India’s 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
  • Biosimilar trials
  • Phase II/III studies
  • Clinical end point trials for bioequivalence assessments
  • Phase IV trials
Project Management

Efficient clinical trial management requires 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 all these plans. 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
Therapeutic Areas and Indications
ONCOLOGY/HEMATO ONCOLOGY
  • Metastatic Breast Cancer (mBC)
  • Metastatic Colorectal Cancer (mCRC)
  • Solid Tumors
  • Gastrointestinal Stromal tumor
  • Non-Small Cell Lung Cancer (NSCLC)
  • Ovarian Carcinoma
  • Prostrate Cancer
  • Hemato Oncology
DERMATOLOGY
  • Acne Vulgaris
  • Psoriasis
  • Scabies
  • Atopic Dermatitis
  • Head Lice
  • Aktinic keratosis
WOMEN’S HEALTH
  • Atrophic Vaginitis
  • Bacterial Vaginosis
  • Dysfunctional Uterine Bleeding
  • Infertility treatments
  • IVF
PSYCHIATRY/NEUROLOGY
  • Epilepsy
  • Schizophrenia
  • Parkinson’s Disease
  • Major Depressive Disorders
GASTROINTESTINAL
  • Functional Dyspepsia
  • Duodenal Ulcers
  • Ulcerative Colitis
  • Traveler’s Diarrhoea
ORTHOPEDIC
  • Rheumatoid Arthritis
  • Osteoarthritis
  • Pain and wound healing
RESPIRATORY
  • Asthma
  • COPD
OPHTHALMOLOGY
  • Cataract
  • Glaucoma
  • Keratoconjunctivitis Sicca
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.

Site Regulatory success

Cliantha works very collaboratively with the research sites prestudy, during study conduct and we support them post study including during regulatory interactions. Outlined below is a sample of the track records from FDA inspections of sites used for patient PK studies.

Indication Number of studies Number of sites inspected Outcome
Oncology 2 4 Successful audits, 2 product approval
Neurology 1 3 Successful audit, product approval pending
Psychiatry 1 1 Successful audit, product approval pending
Site Management
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.

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 even hospitalization as part of the study protocol.

Our research with healthy subjects has made us leader in Phase I. Being leaders in the conduct of early phase clinical studies brings a passion to our team and an easy understanding of the standard requirements for a successful Phase I study conduct in both patients and healthy normal subjects.

You can be assured that your project rests in the hands of a professional team who are experts at the conduct of PK studies. Our team performs close Monitoring of the sites, extensive training of sample handling and management, special observation visits to ensure the correct processes are in place at the sites and detailed manuals and charts for each activity allows the seamless conduct of the study.

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

Clinical Trial Supply Management (CTSM)
  • Cliantha has a dedicated area of approximately 1000 sq. ft (with space for future expansion) for exclusively storing Clinical Trial Investigational products and supplies.
  • Capacity to store Investigational Products (IP) and ancillary supplies at 2-8°C and 15-30°C.
  • Five Refrigerators equipped with calibrated temperature monitoring devices and Alarm panel.
  • SOPs for IP receipt, storage, shipment, destruction and accountability.
  • Restricted entry with controlled access system.
  • Dedicated staff to ensure compliance.

Regulatory Inspections

Last Inspection in Nov 2015
Inspected facility in Nov 2006
Inspected facility in Jan 2009
Last inspection in Apr-May 2016
Inspected facility in Feb - Mar 2013
Last inspection in March 2013
Inspected facility in July 2013
Last inspected by Ministry of Health of Turkey in April 2013
Last inspection in Apr-May 2016