Clinical Trials and BA/BE

At QHI, we understand the emerging needs of Clinical trials. We are geared up towards delivering the qualitative clinical trials.

We offer an unparalleled Clinical trial service across India. We have different strategic partners which have USFDA, EMEA, WHO, UK-MHRA, ANSM, ANVISA, DCGI-India, MCC, and PIC(S)/NPCB-Malaysia facilities, provide a hassle free service to our clients with highest standards of compliance, who are cost effective and meet the timeline of the clients. Our clinical facilities provides global standards having strong SOP driven culture well integrated procedure of clinical research and ensure compliance with all Global Regulatory requirements.

We offer a customizable service package to our clients with single point contact for all your queries with our highly qualified team which is able to assist your study in all aspects. Our veteran team of talented scientists will work with you throughout the stages of clinical studies and ensure of delivery of quality data within time frame.

Clinical trials services for:

• Pharmaceutical products
• Food products/ Neutraceuticals/Dietry suppliment
• Medical Devices & Diagnostic Kits
• Cosmetics
• Herbal/ Ayurvedic/ Unani testing/Ayush Products

Our services details are:

• Highly efficient Regulatory experts team provides regulatory services, which include all type of NOC’s & licenses from DCGI, FSSAI, ISM&H, AYUSH and Ethics committee approvals regarding CT & BA/BE .
• Extensive Investigator network having rich experience and GCP-trained, along with pre-screened clinical sites for all therapeutic indications
• Key opinion leaders/Consultants with rich experience in clinical study design, conduct and safety aspects of Clinical Trials provides comprehensive advice on Clinical development based on the Therapeutic Indication under evaluation and the targeted markets to submit.
• Provide support in Study Design, medical writing, Quality Assurance and Protocol Development
• Experienced and insight management team for in planning, executing Clinical endpoint studies, Pharmacokinetic studies in patient population & Phase I to IVI studies.
• Apart from Indian drug trials, we also offer regarding solution for queries from international regulators of your existing marketed product applications.
• Experienced manpower and vast & diverse volunteer pool comprising healthy elderly, young male and female subjects.
• Dedicated internal quality oriented support staff

Type of studies we are dealing with:

• Early Phase Clinical Trials (Pre-clinical)/Animal Studies
• Toxicological studies
• Clinical trial Phase I to Late phase trial Phase IV
• Fasting and Fed condition Bioequivalence studies/Food effect studies
• PK/PD study of single and multiple dose
• Patient based BE studies with Pharmacokinetic and clinical end-point studies
• Tolerability and pharmacokinetics of escalating single doses
• Tolerability and pharmacokinetics of repeated doses (12 weeks)
• Relative bioavailability of oral formulation
• Absolute bioavailability (IV formulation)
• Drug-drug interaction (DDI)
• Topical Transdermal Patch Studies
• Short to Long residency Studies
• Oral Inhalation Pulmonary deposition & Therapeutic Equivalence Study
• Biowaiver monographs for immediate release oral dosage form

All offered services are customizable and start from study feasibility to final CT or BA/BE report with quality data which including all regulatory approvals from Indian Regulatory Authority (CDSCO) and Ethics Committee approvals (Independent/Institutional).

Bio Analytical Facility

We offer bio analytical facility accredited with NABL with globally accepted system and SOPs. Facility equipped with wide variety of analytical platform like LC/MS/MS, GC-MS-MS, ICP-MS, HPLCs, ELISA etc and having validated methods as per US-FDA guideline.

Statistical Analysis

We provide specialized statistician experts in statistical analysis plan, PK analysis and Sample size calculation by using SAS and WinNonLin.