With fully integrated service package for BE studies-Commitment lies with
- Highest quality clinical services meeting strict ethical norms
- Successful bio-analytical method development and validation of even industry-challenging molecules,
- Professional data management executed through validated processes and reporting services.
- Clinical facility includes spacious subject housing units, segregated counseling and screening areas, fully equipped round the clock ICU, canteen and recreational area, closely monitored and frequently audited kitchen with approved meal plans from dietician.
- Complete confidentiality to our sponsors’ businesses and to our volunteer database.
- Bioavailability / Bioequivalence Studies carried out for of all therapeutic categories & classes of subjects, using in house SOPs developed as per ICH-GCP Guidelines,ICH E3 guideline for bioequivalence report preparation.
- PK data analysis is done by latest version of PK software (WinNonlin 5.2) and final data is evaluated by renowned consultant Bio-statistician.
Path Lab/Diagnostics Services
Central lab services from NABL/CAP accredited labs.
Services with alliance /partner organization.
We also offer Phase I –IV Trials & Data Management services with the collaboration of our partners.
Our clinical team includes Principal investigator, Clinical Investigator, Project Manager, Medical officer Clinical Research Associate, Pharmacist, Medical Writer, Phlebotomist, Staff Nurse, Volunteer development officer, Consultant Biostatistician and Independent Quality Assurance team .
Range of BA-BE service
Auriga Research Limited conducts BA & BE studies for pharmaceutical formulations and for regulatory submission. This includes BE studies intended for submission in ANDA & BE studies conducted in the post approval period for certain changes in both NDA & ANDA.
In BA-BE Centre ARL conducts following types of studies
- Bioavailability/Bioequivalence Studies
- Relative bioavailability of established and experimental formulations
- Single and multiple-dose (Steady state) kinetic studies
- Fasting / Food-effect kinetic studies
- Drug interaction studies
- Studies comparing Immediate and modified release formulations
- Pharmcodynamic studies
- Studies comparing various Routes of Administration
- Studies in Healthy Volunteers / Special Population
Some of the highlights of functioning at BA/BE Centre are:
- Blood and urine sampling for screening
- Dedicated Blood withdrawal area for study samples
- Matrix separation with refrigerated centrifuge
- Dining area and recreation area
- Change room with lockers for volunteers
- Report writing and documentation cell
- Documentation archival room
- A team of highly experienced and motivated professional
- Standard Operating Procedures to comply with ICH-GCP and other international guidelines
- Independent Ethics Committee
- Extensive database of Volunteers (including special population)
- Audited catering services on annual contract with a well qualified Dietician
- Translator on contract for conversion of ICD in vernacular / Hindi language
- Fire drills and patient evacuation drills on regular basis
We have conducted the Bioequivalence study for the following regulatory Successfully
Ukraine, Kazakhstan, Uzbekistan, Moldova, Tajikistan, Philippines, Myanmar, Vietnam, Malaysia
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