Aizant
 
 

Clinical Research
Bioavailability and Bioequivalence
Clinical Trials
Pharmacokinetics and Biostatistics
Clinical Laboratory
Clinical Data Management
   
Bioavailability and Bioequivalence
Aizant clinical research is capable of handling all types of bioavailability (BA)/ bioequivalence (BE) studies in healthy human volunteers as per international conference on harmonization (ICH) - good clinical practice (GCP) guidelines. The studies are accepted for submission to global regulatory agencies.

Our state of the art BA/BE facility is spacious and measures over 40000 square feet and is equipped with the most modern labs and clinics. Exclusive volunteer registration and office areas is spread in the ground floor and two spacious well equipped independent clinics of 40 beds each in the first floor. This allows us to carry out pilot, pivotal and mixed gender studies in compliance with ICH - GCP guidelines.

Our IEC is multidisciplinary and multi-sectorial in composition and formed as per regulatory requirements to safeguard the rights, safety and well being of all the study subjects.

We conduct BA/BE studies (open label/blinded) on various dosage forms like tablets, capsules, extended release preparations, topicals, solutions etc., for the pharmaceutical companies in India and abroad using the following designs;
Parallel
Crossover studies (Two-way, three-way, replicate)
single dose, multidosing , multiple dose, dose escalation
Food interaction studies
Drug interaction studies
Cosmetic and safety evaluation studies
Urine sample studies
Brief summary of the study activities
Protocol and case record form development
IEC applications & approvals
Recruitment and screening
Clinical phase (Housing, dosing & sampling)
Data management and statistical analysis
Clinical report writing
Clinical trials (phase I – IV)
Aizant clinical research is composed of experienced professionals and are capable of conducting
Phase I studies (single /multiple / escalating of dose, molecules of Indian origin or safety established outside India)
Phase II-IV studies (for wide range of therapeutic areas and indications)
The state of the art clinical lab is well equipped with central monitoring system for close monitoring of the study subjects.
Pharmacokinetics and biostatistics
Aizant has a dedicated pharmacokinetics and biostatistics team to provide statistical support needed for all aspects of product development.

We use current version of software like
SAS and WINONLIN which enable us to respond to a project needs in a timely manner.
Our team has expertise in analyzing, interpretation and reporting of clinical data and also collaborates with various clinical departments for designing case report forms ( CRFs) and calculation of sample size required for the project.
Clinical Laboratory Services
Clinical laboratory is established to support clinical research. Our clinical lab offers a wide range of tests to meet the clients requirements. All the processes in the lab are automated and integrated to laboratory information management system (LIMS).
Hematology
Biochemistry and electrolytes
Immunology / Serology
Coagulation
Urine analysis
Clinical pathology
Radiology
Clinical Data Management
We provide comprehensive data management services in pre-clinical, bio-equivalence and phase I-IV clinical trials to expedite the regulatory submission process and shorten timelines.
Study design & analysis planning
Data system designing and support
CRF design and production
Data entry and management
Data summary and report
Data quality audits