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Clinical Research |
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Bioavailability and Bioequivalence |
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Clinical Trials |
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Pharmacokinetics and Biostatistics |
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Clinical Laboratory |
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Clinical Data Management |
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| 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; |
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Parallel |
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Crossover studies (Two-way, three-way, replicate)
single dose, multidosing , multiple dose, dose escalation |
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Food interaction studies |
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Drug interaction studies |
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Cosmetic and safety evaluation studies |
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Urine sample studies |
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| Brief summary of the study activities |
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Protocol and case record form development |
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IEC applications & approvals |
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Recruitment and screening |
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Clinical phase (Housing, dosing & sampling) |
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Data management and statistical analysis |
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Clinical report writing |
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| 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 |
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SAS and WINONLIN which enable us to respond to a project needs in a timely manner. |
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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.
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