Chemxtree Standards’ team brings in considerable experience in conducting Bioavailability & Bioequivalence studies on healthy as well as patient population with various dosage forms including injectables like IM/IV/SC, Oral dosage forms like Solid Formulations (Modified Release Preparations), Liquid Formulations, Topical Preparations & Inhalations.
The BA/BE studies conducted at Chemxtree are under a fully GCP-compliant facility. The team consists of medical professionals supported by a team of clinical investigators, pathologists, physicians, clinical research associates, pharmacists, paramedics, and laboratory technicians, as well as well-equipped ICU facilities, state-of-art equipment, regulatory compliance software, and secured networks. We have a strong SOP-driven culture & ensure compliance with all statutory & mandatory requirements. We also support the regulatory queries at each step arising post submissions.
Experience in handling various Dosage forms:
Oral Dosage Forms [Tablet/Capsule (IR, DR, MR, SR, CR, ODT)]
Inhalation/Pulmonary [MDI, DPI, Nasal Spray]
Injectable Formulations [IM, SC, IV]
Transdermal Patch Studies
Topical Transdermal Gel & Cream
Vaginal, Suppository
Sublingual
Cosmetics
Suspensions/Liquids
Experts in Different Types of Studies Design:
Parallel Design
Two-Way Cross Over
Three-Way Cross-Over/Partially Replicate Studies
Four-Way Cross-Over/Fully Replicate Studies
Fasting/Fed/Sprinkle Applesauce
Complex generics
Long Duration-Continous Monitoring Trials
Special Population Trials
Post-Menopausal Study
Salient Features of Clinical Facility:
The facility has separate access-controlled wards for Males & Females Volunteers
More than 20,000 diversified volunteers’ database of Males, Females, Post-Menopausal Females & Geriatric
Advanced software for Volunteer management
Central Monitoring with CCTV
Sample collection room having multiple stations matrix collections with separate matrix processing room
pharmacy with biometric access
Dining area is supervised by a qualified dietician
In-House ECG facility
ICF, Documentation & Biometry with software to ensure identity and avoid cross-participation
Activity wise separate rooms for screening, counseling with audio-video recording
Our aim is to offer enhanced CRO solutions on time while maintaining the highest levels of quality, cost-effectiveness, data integrity, and operational excellence