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

180
Studies
20
Therapeutic Categories
90
Indications
1800
Sites
28400
Patients
56
USFDA Audits

Regulatory History

Sr. No. Agency Inspection Date Country Location Specialty
1 USFDA 15 Jan - 19 Jan 2024 India Ahmedabad Dermatology
2 USFDA 04 Jan - 09 Jan 2024 India Gurugram Dermatology
3 USFDA 28 Dec - 30 Dec 2023 India Bangalore Dermatology
4 USFDA 04 Dec - 06 Dec 2023 India Ahmedabad Dermatology
5 USFDA 06 Nov – 09 Nov 2023 India Surat Dermatology
6 USFDA 30 Oct – 01 Nov 2023 India Nagpur Dermatology
7 USFDA 11 Sep - 15 Sep 2023 India Gandhinagar Respiratory
8 USFDA 07 Sep - 13 Sep 2023 India Vadodara Respiratory
9 USFDA 17 Apr - 21 Apr 2023 India Bikaner Oncology
10 USFDA 06 Mar - 10 Mar 2023 India Nashik Oncology
11 USFDA 06 Feb – 10 Feb 2023 India Pune Oncology
12 USFDA 12 Dec - 15 Dec 2022 India Ahmedabad Orthopedics
13 USFDA 5 Dec - 8 Dec 2022 India Ahmedabad Orthopedics
14 USFDA 25 Apr - 29 Apr 2022 India Kozhikode Psychiatry
15 USFDA 19 Apr - 22 Apr 2022 India Mysuru Psychiatry
16 USFDA 20 Jan - 11 Mar 2021 India Pune Dermatology
17 USFDA 08 Jan - 08 Mar 2021 India Varanasi Dermatology
18 USFDA 18 Dec - 21 Jan 2021 India Hyderabad Psychiatry
19 USFDA 27 Jan - 31 Jan 2020 India Belagavi Dermatology
20 USFDA 15 Jan - 21 Jan 2020 India Ahmedabad Orthopedics
21 USFDA 18 Nov - 22 Nov 2019 India Mumbai Orthopedics
22 USFDA 18 Nov - 22 Nov 2019 India Mumbai Dermatology
23 USFDA 18 Nov - 21 Nov 2019 India Ahmedabad Orthopedics
24 USFDA 11 Nov - 15 Nov 2019 India Vijayawada Psychiatry
25 USFDA 11 Nov - 15 Nov 2019 India Pune Psychiatry
26 USFDA 04 Nov - 08 Nov 2019 India Nashik Dermatology
27 USFDA 04 Nov - 08 Nov 2019 India Hubbali Orthopedics
28 USFDA 04 Nov - 08 Nov 2019 India Pune Psychiatry
29 USFDA 21 Oct - 25 Oct 2019 India Dombivli Dermatology
30 USFDA 14 Oct - 18 Oct 2019 India Kanpur Orthopedics
31 USFDA 11 Sep - 14 Sep 2019 India Junagadh Psychiatry
32 USFDA 02 Sep - 06 Sep 2019 India Ahmedabad Orthopedics
33 USFDA 13 Aug - 20 Aug 2019 India Ahmedabad Dermatology
34 USFDA 13 Aug - 20 Aug 2019 India Ahmedabad Orthopedics
35 USFDA 29 Jul - 02 Aug 2019 India Ahmedabad Psychiatry
36 USFDA 05 Mar - 07 Mar 2019 India Mumbai Dermatology
37 USFDA 05 Feb - 08 Feb 2019 India Lucknow Dermatology
38 USFDA 14 Nov - 16 Nov 2018 India Lucknow Dermatology
39 USFDA 17 Sep - 20 Sep 2018 India Himmatnagar Orthopedics
40 USFDA 30 May - 01 Jun 2018 India Pune Neurology
41 USFDA 28 May - 05 Jun 2018 India Gandhinagar Neurology
42 USFDA 11 Apr -13 Apr 2018 India Goa Oncology
43 USFDA 12 Mar - 16 Mar 2018 India Bangalore Oncology
44 USFDA 16 Jan - 18 Jan 2018 USA Omaha, Nebraska Dermatology
45 USFDA 11 Dec - 13 Dec 2017 India Mumbai Dermatology
46 USFDA 04 Dec - 06 Dec 2017 India Bangalore Dermatology
47 USFDA 15 Nov - 18 Nov 2017 India Ahmedabad Psychiatry
48 USFDA 20 Feb - 24 Feb 2017 India Pune Psychiatry
49 USFDA 23 Jan - 26 Jan 2017 India Junagadh Psychiatry
50 USFDA 07 Nov - 10 Nov 2016 India Surat Neurology
51 USFDA 15 Aug - 19 Aug 2016 India Pune Neurology
52 USFDA 08 Aug - 12 Aug 2016 India Gandhinagar Neurology
53 USFDA 25 Aug - 28 Aug 2014 India Vadodara Oncology
54 USFDA 28 Jul - 31 Jul 2014 India New Delhi Oncology
55 USFDA 24 Mar - 27 Mar 2014 India Madurai Oncology
56 USFDA 24 Feb - 27 Feb 2014 India Nagpur Oncology

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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 19 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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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 2500 sq. ft. (with space for future expansion) for exclusively storing Clinical Trial investigational products and supplies with 24 x 7 engineering personal availability.
  • Capacity to store investigational Products (IP) and ancillary supplies at +2 to +8°C, +15 to +30°C and Below -20°C.
  • Six Refrigerators and two deep freezers 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