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 & Expertise

53
Studies
10
Therapeutic Categories
31
Indications
730
Sites
13388
Patients

Therapeutic Experience India

Therapeutic area No of studies No of Indications No of sites No of patients involved
Dermatology 12 4 176 4698
Oncology 12 7 190 1294
Neuropsychiatry 10 3 86 916
Gastrointestinal 4 3 16 290
Immune Disorder 4 3 24 162
Respiratory 4 2 119 2494
Gynecology 2 2 21 269
Infectious diseases 2 3 20 634
Orthopedic 2 1 65 2328
Cardiovascular 1 1 13 303

Therapeutic experience molecule wise

THERAPEUTIC AREA INDICATION MOLECULE NO.OF SITE TOTAL SAMPLE SIZE
Oncology Metastatic breast/Colorectal cancer Capecitabine 14 54
Oncology Metastatic breast/Colorectal cancer Capecitabine 10 42
Oncology GIST and CML Imatinib Mesylate 400mg  6 38
Oncology Metastatic Breast Cancer Trastuzumab 34 102
Oncology Metastatic Breast Cancer Paclitaxel 21 90
Oncology Diffuse large B-cell lymphoma Rituximab  13 73
Oncology Metastatic colorectal cancer Bevacizumab 6 24
Oncology Metastatic colorectal cancer Bevacizumab 26 111
Oncology NSCLC Bevacizumab 30 650
Oncology NSCLC NCE 10 60
Oncology Thyroid Cancer  Lenvatinib 10 50
Dermatology Acne Vulgaris Clindamycin + Benzoyl Peroxide 10 60
Dermatology Acne Vulgaris Clindamycin + Benzoyl Peroxide 26 850
Dermatology Acne Vulgaris Clindamycin + Benzoyl Peroxide 20 530
Dermatology Acne Vulgaris Clindamycin + Benzoyl Peroxide 20 910
Dermatology Acne Vulgaris Adapalene BPO 25 790
Dermatology Acne Vulgaris Adapalene BPO 20 550
Dermatology Scabies Permethrine 10 154
Dermatology Scabies Permethrine 10 154
Dermatology Scabies Permethrine 2 18
Dermatology Scabies Permethrine 10 300
Dermatology Head Lice Ivermectin Lotion 15 350
Dermatology  Psoriasis  Methotrexate 8 32
Neuropsychiatry  Adult Epilepsy Felbamate Tablet 6 30
Neuropsychiatry  Schizophrenia Clozapine  6 36
Neuropsychiatry  Schizophrenia Clozapine  6 36
Neuropsychiatry  Schizophrenia Clozapine  6 40
Neuropsychiatry  Schizophrenia Paliperidone LAI - 1M 15 264
Neuropsychiatry  Schizophrenia Paliperidone LAI - 3M 13 264
Neuropsychiatry  Schizophrenia Risperidone 12 88
Neuropsychiatry  Schizophrenia Aripiprazole ER Inj 10 88
Neuropsychiatry  Idiopathic Parkinson’s Pramipexole 6 40
Neuropsychiatry  Adult Epilepsy Felbamate 6 30
Respiratory Moderate or sever COPD Glycopyrronium and Formoterol 14 330
Respiratory Persistent Asthma Beclomethasone Dipropionate  35 480
Respiratory Mild Or Moderate Persistent Asthma Beclomethasone Dipropionate  35 480
Respiratory Asthma Fluticasone Propionate & Salmeterol 35 1204
Immune Disorder Rheumatoid Arthritis Methotrexate 8 32
Immune Disorder HIV-1 Infection Nevirapine ER 6 36
Immune Disorder HIV-1 Infection Nevirapine ER 5 30
Immune Disorder Rheumatoid Arthritis Azathioprine 5 64
Gastrointestinal Dyspepsia Acotiamide 13 222
Gastrointestinal Ulcers Rabeprazole  - Baseline 1 6
Gastrointestinal Ulcers Rabeprazole  - Extension 1 12
Gastrointestinal CKD Probiotic  1 50
Gynecology Uterine Fibroids Ulipristal acetate 12 153
Gynecology IVF Recombinant Human FSH 9 116
Infectious disease Tricuria Infection (whipworm) Mebendazole 15 494
Infectious disease Visceral Leishmaniasis  Amphotericin B Liposome 5 140
Orthopedic Osteoarthritis  Diclofenac Sodium  40 1212
Orthopedic Osteoarthritis  Diclofenac Sodium  25 1116
Cardiovascular Hypertension Azilsartan  13 303

Regulatory History

12 Consecutive inspections with no form 483
Sr. No. Agency Inspection Date Country Location Specialty
1 USFDA 05 Mar - 07 Mar 2019 India Mumbai Dermatology
2 USFDA 05 Feb - 08 Feb 2019 India Lucknow Dermatology
3 USFDA 14 Nov - 16 Nov 2018 India Lucknow Dermatology
4 USFDA 17 Sept - 20 Sept 2018  India Himmatnagar   Osteoarthritis
5 USFDA 30 May – 01 Jun 2018 India Pune  Neurology
6 USFDA 28 May – 05 Jun 2018 India Gandhinagar  Neurology
7 USFDA 11 Apr - 13 Apr 2018 India Goa  Oncology
8 USFDA 12 Mar - 16 Mar 2018 India Bangalore  Oncology
9 USFDA 16 Jan - 18 Jan 2018 USA Omaha, Nebraska, USA Dermatology
10 USFDA 11 Dec - 13 Dec 2017 India Mumbai Dermatology

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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 14 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, Neptune, NJ & Mississauga

  • 6 clinical units, 248 beds, 19 ICU beds
  • Complete On-Site Pharmacy
  • 20,000 square-foot clinic area

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.
Indication Number of sites inspected Outcome
Oncology 6 Successful audits, 2 product approval
Neurology 5 Successful audit, product approval pending
Psychiatry 3 Successful audit, product approval pending
Dermatology 5 Successful audit, product approval pending
Osteoarthritis 1 Successful audit, product approval pending
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