Late Phase

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


Experience

97
Studies
21
Therapeutic Categories
52
Indications
1074
Sites
18322
Patients

Therapeutic Experience

Therapeutic Category Studies Sites Subjects
Neuropsychiatry  21 186 2543
Oncology 18 258 1538
Dermatology 12 188 5537
Respiratory 9 116 1320
Gastrointestinal 5 26 295
Orthopedic 5 88 2696
Immunology 4 24 162
Ophthalmology 4 41 1089
Allergy  3 15 246
Neurology 3 55 1007
Gynecology 2 21 269
Infectious disease 2 21 474
Nephrology 2 6 135
Cardiovascular 1 13 303
Dental 1 8 220
Endocrinology 1 4 195
Others 4 4 293

Regulatory History

Sr. No. Agency Inspection Date Country Location Specialty
1 USFDA 20 Jan 21 - 11 Mar 21 India Pune Dermatology
2 USFDA 08 Jan - 08 Mar 21 India Varanasi Dermatology
3 USFDA 18 Dec 20 - 21 Jan 21 India Hyderabad Psychiatry
4 USFDA 27 Jan - 31 Jan 20 India Belagavi   Dermatology
5 USFDA 15 Jan - 21 Jan 20 India Ahmedabad  Orthopedics
6 USFDA 18 Nov - 22 Nov 19 India Mumbai  Orthopedics
7 USFDA 18 Nov - 22 Nov 19 India Mumbai Dermatology
8 USFDA 18 Nov - 21 Nov 19 India Ahmedabad  Orthopedics
9 USFDA 11 Nov - 15 Nov 19 India Vijayawada  Psychiatry
10 USFDA 11 Nov - 15 Nov 19 India Pune  Psychiatry
11 USFDA 04 Nov - 08 Nov 19 India Nashik  Dermatology
12 USFDA 04 Nov - 08 Nov 19 India Hubbali  Orthopedics
12 USFDA 04 Nov - 08 Nov 19 India Pune  Psychiatry

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Integrated departments

Medical Writing

Medical writers are responsible for preparing the study protocols in line with the sponsor’s requirements and applicable regulatory guidance. The medical writing team also coordinates with the ethics committee for the necessary approvals

  • Protocol development
  • Protocol amendments
  • Informed Consent Forms
  • Case Report Form preparation
  • Clinical study reports
  • Bioanalytical sample analysis reports
  • Method validation report
  • Biostatistical reports

Our medical writing services are in full compliance with applicable regulatory requirements.

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Central Lab

With 15 years of therapeutic expertise & scientific knowledge, Cliantha strictly abides by the quality parameters required for clinical testing. We continuously update & validate our new test methods & appraise industry trends to enhance our capabilities.

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India

Location: Ahmedbad, Vadodara, Noida

  • 12 clinical units, 513 beds, 14 ICU beds & 20 doctors
  • 30,000 square-foot clinic area
  • Intensive Care Units with continuous cardiac monitoring
  • 24/7 medical surveillance
  • Dedicated phlebotomists
  • Experienced physicians, nurses and clinical staff
  • Refrigerated Centrifuges
  • Humidity Chambers
  • -30°C and -80°C storage facility
North America

Location: St. Petersburg, FL & Mississauga

  • 4 clinical units, 138 beds, 8 ICU beds
  • Complete On-Site Pharmacy

Bioanalytical Lab

Our team is committed to meet your critical study milestones with high quality data to facilitate your product development decisions. Our team has significant experience with small and large molecules using LC/MS/MS and ICP-OES equipment to support New Chemical Entities (NCE), biologic, biosimilar and generic drug development. We blend all our quality systems with efficient and validated processes to deliver high quality data on time.

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Regulatory

Cliantha Research has been successfully inspected or audited by various regulatory agencies across the globe. Our impeccable regulatory track record is the result of strict adherence to the applicable standard(s) and guidelines laid by ICH, FDA, EMA, Clinical and Bio-Analytical bodies. Our enshrined values : Science & Integrity are the foundation for our planning and execution assisted with robust knowledge of the regulations.

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Key Offerings

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
Site selection
  • 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.
Therapeutic Category Number of sites inspected
Dermatology 11
Osteoarthritis 8
Psychiatry 8
Oncology 6
Neurology 5
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.

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 services (including reporting to authorities and EC’s)
  • Drug importation and distribution
  • Preparation and conduct of investigator meetings
  • Site management
  • Quality assurance