Early Phase Trials Phase I (BA/BE, PK)

Comprehensive Services
State-Of-The-Art Facilities
Experience & Expertise
Regulatory Audits

At ADVITY, Our early-phase portfolio includes BA/BE studies, Phase I studies (conducted in healthy participants and special populations) and PK/PD & patient studies (conducted in special populations). Our BA/BE study services are fully compliant with global regulatory requirements.

Comprehensive Services

BA/BE Studies – on healthy participants & patients

Extensive cardiac monitoring studies

Bioanalysis of first in human studies

PK/PD & Clinical end point studies on healthy participants & patients

Palatability evaluation studies

Pharmacokinetic & Biopharmaceutics

Studies on special populations – healthy female, PMW & elder participants

Medical writing services : Protocol development, ICD, ICF and Clinical study reports

Statistical analysis and Population BA/BE analysis

Proof-of-concept studies (PK Studies)

Bioanalytical services: For small & large molecule analysis and elemental analysis

Data Management & CDISC services

Glucose Clamping studies

Pre-clinical PK sample analysis

State-Of-The-Art Facilities

A state-of-the-art facility spanning approximately 42,000 sq. ft., well-connected to all major parts of the city.
Comprehensive emergency infrastructure to ensure the safety and emergency handling of participants.
A volunteer cross-participation verification system to ensure right participants take part in the study.
In-house developed eDC tool for seamless data capture without integrity issues.
Clinical pharmacology units with bed capacity to accommodate 10,000 doses per year.
Additional clinical pharmacology units under development to accommodate an additional 8,000 doses per year.

State-of-the-art Intensive Care Unit with modern infrastructure to handle basic emergency requirements during clinical studies.
A In-house X-ray and ECG facilities.
Partnership with a tertiary care hospital for emergency handling.
Association with NABL accredited path labs to select the right participants for the study.
Humidity chambers for the storage of investigational products.
Archival facility with sufficient space for future expansion.
State-of-the-art bioanalytical facility with advanced analytical infrastructure.

Advanced LC-MS/MS systems to accommodate bioanalytical methods up to 1 pg/ml.
Deep freezers to store extended volumes of biological samples.
State-of-the-art large molecule analytical facility – ELISA.
Eurotherms installed across the analytical facility to monitor temperatures.
Cutting-edge IT infrastructure with SonicWall firewalls, Dell servers with RAID-5 configuration, NAS storage with RAID-5, and Kaspersky Antivirus for robust security.
SAS version 9.4 system fully validated.

Experience & Expertise

5000+

Experience in execution of more than 5000+ PK studies which includes BA/BE studies in healthy participants and patients.

60+

The team has successfully faced over 60+ global regulatory audits, including USFDA, EMEA, UKMHRA, and ANVISA.

800+

Hands-on experience with 800+ analytical methods, including complex, low-sensitivity molecules (Pg/mL) and NCEs.

200+

Experience with 200+ Pharma and biotech companies worldwide, including major pharmaceutical firms.

3500+

Extensive experience in executing 3500+ clamps with a well-established glucose clamping facility.

Experience

Experience in complex dosage forms, special populations, diverse routes, long washout, and prolonged housing studies.

Regulatory Audits

Connect with our Head of BA/BE to discuss your next project

Services