Bioavailability and Bioequivalence Services Clinical Data Management Central Reference Lab Clinical Trials and Research Site Management Services     BIOAVAILABILITY AND BIOEQUIVALENCE SERVICES (PK/PD)   We have expertise in bioavailability, bioequivalence service and pharmacokinetic studies. We offer end to end service ranging from Regulatory Consultancy, Clinical Dosing, Bio-analytical, Bio-statistical, Data Management services and complete Study Report writing as per regulatory guidelines and client requirement. Studies are performed on various dosage forms like tablets, capsules, ER and IR formulation, transdermal patch, Inhalation devices and special food effect studies. Sponsors may opt for services on a stand alone basis or in an integrated manner.   We conduct studies in compliance with National and International Regulatory requirements, strictly monitored by an independent quality assurance department. Underwriters Laboratory has certified our processes to comply with ISO 9001 and for information security with ISO 27001. Protocols are reviewed by an Independent Ethics Committee, which is registered with Office of Human Research Protection, US Dept of Health & Human Services. Our centers have successfully passed audits conducted DCGI (India) and Global sponsors. Our studies have undergone regulatory audits, notable being the USFDA and WHO.. Our study data is part of drug dossiers filed with regulatory authorities in India, EU and US.   Our state of the art BA/BE center includes Clinical Pharmacological Units (CPU) located at Manipal and Mangalore, India. The 84 bed CPU is designed for mixed gender studies. In addition we have access to a 60 bedded CPU in Bangalore, which is designed for large pivotal studies. CPU's are equipped with ICU, located in Specialty Hospital campus and are designed to meet high standards of volunteer safety. We have in house CAP certified Clinical Testing lab and Bio-analytical laboratory equipped with a bank of LC MS/MS. We have a library of validated methods. Team is experienced and well trained in ICH-GCP and GLP guidelines.   We have a quality volunteer data base of over 4000 volunteers which includes post menopausal women, geriatric volunteers, renal and hepatic impaired volunteers. We can conduct studies on patients in Oncology and other indications.        Our full range of services in clinical research covers:    . Regulatory consultancy    . Protocol development    . Volunteer screening and Central Lab Service    . Clinical study and project management    . Adverse event reporting and Emergency treatment  . Method development, Validation and Analysis  . Pharmacokinetic Analysis  . Statistical analysis and data management  . Report writing and submission  . Specimen storage and archival   After a benchmarking study of BA/BE centers in India, Frost & Sullivan named us as ‘Partner of Choice in BA/BE services’ For more information please email : pkpd@acunovalife.com

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