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
|Sr. No.||Agency||Inspection Date||Country||Location||Specialty|
|1||USFDA||25 Apr - 29 Apr 2022||India||Kozhikode||Psychiatry|
|2||USFDA||19 Apr - 22 Apr 2022||India||Mysuru||Psychiatry|
|3||USFDA||20 Jan 21 - 11 Mar 21||India||Pune||Dermatology|
|4||USFDA||08 Jan - 08 Mar 21||India||Varanasi||Dermatology|
|5||USFDA||18 Dec 20 - 21 Jan 21||India||Hyderabad||Psychiatry|
|6||USFDA||27 Jan - 31 Jan 20||India||Belagavi||Dermatology|
|7||USFDA||15 Jan - 21 Jan 20||India||Ahmedabad||Orthopedics|
|8||USFDA||18 Nov - 22 Nov 19||India||Mumbai||Orthopedics|
|9||USFDA||18 Nov - 22 Nov 19||India||Mumbai||Dermatology|
|10||USFDA||18 Nov - 21 Nov 19||India||Ahmedabad||Orthopedics|
|11||USFDA||11 Nov - 15 Nov 19||India||Vijayawada||Psychiatry|
|12||USFDA||11 Nov - 15 Nov 19||India||Pune||Psychiatry|
|13||USFDA||04 Nov - 08 Nov 19||India||Nashik||Dermatology|
|14||USFDA||04 Nov - 08 Nov 19||India||Hubali||Orthopedics|
|15||USFDA||04 Nov - 08 Nov 19||India||Pune||Psychiatry|
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
Our medical writing services are in full compliance with applicable regulatory requirements.
With 18 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.
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.
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.
Efficient clinical trial management requires focus on many aspects at the same time.
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:
|Therapeutic Category||Number of sites inspected|
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.
With our robust feasibility studies, you can rest assured that your studies will complete on time and within budget.
Clinical Trial Supply Management (CTSM)