Late Phase

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