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

49
Studies
11
Therapeutic Categories
31
Indications
690
Sites
175
Patients

Therapeutic Experience India

Therapeutic area No of studies No of Indications No of sites No of patients involved
Oncology 18 9 260 1800+
Dermatology 16 5 260 9000+
Psychiatry 7 2 54 550+
Neurology 6 3 50 500+
Orthopedic 4 4 80 2400+
Gastroenterology 4 3 15 700+
Gynecology 3 3 54 600+
Infectious diseases 3 3 15 140+
Cardiovascular 1 1 13 210
Immunology 1 1 5 30
Respiratory 1 1 14 330+

Therapeutic experience molecule wise

THERAPEUTIC AREA INDICATION MOLECULE NO.OF SITE TOTAL SAMPLE SIZE
Oncology Oncology Metastatic breast cancer Capecitabine 14 54
Oncology Oncology Metastatic breast cancer Capecitabine 10 42
Oncology GIST and CML Imatinib Mesylate 6 38
Oncology Diffuse large B-cell lymphoma Rituximab 13 73
Oncology Metastatic colorectal cancer Bevacizumab 6 40
Oncology Metastatic colorectal cancer Bevacizumab 26 137
Oncology Metastatic colorectal cancer Trastuzumab 34 102
Oncology NSCLC Bevacizumab 31 200
Oncology NSCLC Bevacizumab 30 478
Oncology Facilitate Recruitment Imatinib Mesylate 10 -
Oncology Metastatic Breast Cancer Paclitaxel 17 90
Oncology Metastatic Breast Cancer Trastuzumab 20 200
Oncology NSCLC NCE 10 60
Oncology Diffuse large B-cell lymphoma Rituximab 30 200
Oncology Renal Cell Carcinoma Lenvatinib 8 50
Oncology Advanced Overian Cancer Olaparib Tablets 6 18
Oncology Multiple Myeloma Carfilzomib Under Regulatory approval
Oncology Advanced Renal Cell Carcinoma Pazopanib 15 126
Dermatology  Acne Vulgaris  Clindamycin + Benzoyl Peroxide 10 60
Dermatology  Acne Vulgaris  Clindamycin Phosphate 26 850
Dermatology  Scabies Permethrine 10 154
Dermatology  Scabies Permethrine 1 18
Dermatology  Acne Vulgaris Clindamycin + Benzoyl Peroxide 20 530
Dermatology  Acne Vulgaris Clindamycin + Benzoyl Peroxide 20 910
Dermatology  Head Lice Ivermectin 20 350
Dermatology  Acne Vulgaris Clindamycin Tretinoin 25 1095
Dermatology  Acne Vulgaris Clindamycin 25 995
Dermatology  Scabies Permethrin 20 1400
Dermatology  Rosacea Ivermectin 1% 20 650
Dermatology  Acne Vulgaris Adapalene 25 790
Dermatology  Acne Vulgaris Adapalene and Benzoyl peroxide 20 550
Dermatology  Scabies Permethrin 5% Under Regulatory approval
Dermatology  Acne Vulgaris Clindamycin 25 995
Dermatology  Psoriasis Methotrexate 8 32
Psychiatry Schizophrenia or Schizoaffective Disorder Clozapine ODT 6 36
Psychiatry Schizophrenia or Schizoaffective Disorder Clozapine 7 36
Psychiatry Schizophrenia or Schizoaffective Disorder Clozapine 6 40
Psychiatry Schizophrenia or Schizoaffective Disorder Clozapine ODT 6 40
Psychiatry Schizophrenia or Schizoaffective Disorder Cariprazine Capsules 6 50
Psychiatry Schizophrenia or Schizoaffective Disorder Paliperidone LAI - 3M 13 264
Psychiatry Schizophrenia or Schizoaffective Disorder Aripiprazole 10 88
Neurology Epilepsy Felbamate 7 30
Neurology Idiopathic Parkinson’s Pramipexole 6 40
Neurology Epilepsy Felbamate 6 30
Neurology Schizophrenia Asenapine 6 24
Neurology Schizophrenia Paliperidone 13 266
Neurology Schizophrenia Risperidone 12 100
Orthopedic Osteoarthritis Diclofenac Sodium 40 1212
Orthopedic Osteo Arthritis Diclofenac 25 1116
Orthopedic Rheumatoid Arthritis Azathioprine 6 64
Orthopedic Rheumatoid Arthritis Methotrexate 8 32
Gastrointestinal Dyspepsia Acotiamide 13 222
Gastrointestinal CKD CUDO FORTE 2 100
Gastrointestinal Chronic Idiopathic Constipation Linaclotide 10 400
Gastrointestinal Chronic Idiopathic Constipation (CIC). Plecanatide Under Regulatory approval
Gastrointestinal Healthy Human Rabeprazole 1 6
Gynecology Uterine Fibroids Ulipristal acetate 12 153
Gynecology IVF r-hFSH 9 116
Gynecology Vulvar & Vaginal atrophy Estradiol 33 345
Infectious disease Severe Sepsis Ulinastatin 8 116
Infectious disease Tricuria Infection Mebendazole 15 312
Infectious disease VL, Fungal Infection, Crytococc. Infection Amphoterecin 15 140
Immune HIV-1 infection Nevirapine ER 5 30
Cardiovascular Hypertension Azilsartan 13 210
Respiratory Moderate or severCOPD Formeterol + Glycopyronate 14 330

Regulatory History

12 Consecutive inspections with no form 483
Sr. No. Agency Inspection Date Specialty Name of Molecule Location Inspection Area
1 USFDA 24-27 Feb 14 Oncology Capecitabine Tablets Nagpur GCP
2 USFDA 24-27 Mar 14 Oncology Capecitabine Tablets Madurai GCP
3 USFDA 28-31 Jul 14 Oncology Capecitabine Tablets New Delhi GCP(No 483)
4 USFDA 25-28 Aug 14 Oncology Capecitabine Tablets Vadodara GCP(No 483)
5 USFDA 08-12 Aug 16 Neurology Felbamate Tablets Gandhinagar GCP
6 USFDA 15-19 Aug 16 Neurology Felbamate Tablets Pune GCP
7 USFDA 07-10 Nov 16 Neurology Felbamate Tablets Surat GCP(No 483)
8 USFDA 23-26 Jan 17 Psychiatry Clozapine Tablets Junagadh GCP(No 483)
9 USFDA 20-24 Feb 17 Psychiatry Clozapine Tablets Pune GCP(No 483)
10 USFDA 15-18 Nov 17 Psychiatry Clozapine ODT Ahmedabad GCP(No 483)
11 USFDA 04-06 Dec 17 Dermatology Clindamycin Phosphate & Benzoyl Peroxide Topical Gel Bangalore GCP(No 483)
12 USFDA 11-13 Dec 17 Dermatology Clindamycin Phosphate & Benzoyl Peroxide Topical Gel Mumbai GCP(No 483)
13 USFDA 16-18 Jan 18 Dermatology Clindamycin Phosphate & Benzoyl Peroxide Topical Gel Omaha, Nebraska, USA GCP(No 483)
14 USFDA 12-16 Mar 18 Oncology Paclitaxel Protein-bound Particles for Injectable Suspension Bangalore GCP(No 483)
15 USFDA 11-13 Apr 18 Oncology Paclitaxel Protein-bound Particles for Injectable Suspension Goa GCP(No 483)
16 USFDA 28 May – 05 Jun 18 Neurology Felbamate Suspension Gandhinagar GCP(No 483)
17 USFDA 30 May – 01 Jun 18 Neurology Felbamate Suspension Pune GCP(No 483)
18 USFDA Sept 17’- Sept 20’ Osteoarthritis Diclofenac gel Himmatnagar GCP(No 483)

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