You may be interested in
COVID-19 Vaccination Programs & Implications
Of The Human Microbiome
Comprehensive Solutions
BA/BE Studies – On Healthy subjects & Patients
Extensive Cardiac Monitoring studies
Bioanalysis of first in human studies
Palatability Evaluation studies
Studies on special populations – Healthy Female, PMW & Elder Subjects
Proof-of-concept studies (PK Studies)
PK/PD & Clinical end point studies on Healthy subjects & Patients
Statistical analysis and Population BA/BE analysis
Medical writing services : Protocol development, ICD, ICF and Clinical study reports
Bioanalytical services: for Small & Large molecule analysis and Elemental analysis
Data Management & CDISC services
Pharmacokinetic & Biopharmaceutics
Glucose Clamping studies
Pre-clinical PK Sample analysis
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Clinical Operations – Facilities & Team
- State-of-the-art Clinical facility spread over 14,000 Sq. Ft.
- The clinical facility is well connected to all major parts of the city
- Total of 94 beds, distributed over 04 clinical wards
- Clinics are designed to support small, medium, and large-sized studies
- Dedicated state of the art special care unit: consist of 05 beds and equipped with all the required infrastructure
- Collaborated with the Tertiary Care Hospital (100 bedded super specialty hospital) for handling emergency situations
- The clinical team has undergone extensive training in GCP and emergency handling procedures
- A comprehensive emergency response infrastructure, in place
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Clinical Operations – Facilities & Team
- Collaborated with NABL accredited clinical path labs
- All the vital equipment's are 21 CFR Part 11 complaint
- All clinical areas have provisions for handling light sensitive molecules
- Clinical area is completely under CCTV surveillance
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Clinical Operations – Facilities & Team
- Dedicated area for audio/video recording, allow volunteers to consent one-on-one
- Pharmacy area: Humidity chamber and Cold chamber
- In-house X-Ray facility
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Clinical Operations – Facilities & Team
- All clinical operations are Digitalized
- Bar-coding system
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Bioanalytical Operations – Facilities & Team
- State-of-the-art Bioanalytical facility spread over 7,000 Sq.Ft.
- Analytical facility can accommodate a total of 11 LC-MS/MS. We have started with 05 LC-MS/MS - API 4500. Additional LC-MS/MS will be accommodated in a quick turn around time
- A well-equipped sample storage facility equipped with high-end data loggers for monitoring temperature
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Bioanalytical Operations – Facilities & Team
- Total of 09 freezers on board, -700C (04), -200C (03) and 040C (02) are installed
- Sample storage facility : Capacity of more than 100,000 samples
- With the current infrastructure, 20,000 samples can be analyzed per month
- Temperature monitoring devices and data loggers are located throughout the analytical facility to monitor the temperature
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Bioanalytical Operations – Facilities & Team
- Dedicated sample preparation work stations for both small and large molecules
- Provisions for handling light sensitive molecules
- Team of qualified individuals with experience of 04 - 20 years
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Bioanalytical Operations – Facilities & Team
- Software's used in the analytical equipment’s are 21 CFR PART 11 compliance
- Provision for large molecule analysis (Ligand binding assays) using ELISA
- Robust BCP in place for Bioanalytical systems and process
Experience & Expertise
- Experience in execution of more than 4000+ BA/BE projects for various regulatory markets
- Team has experience in handling various complex BA/BE studies such as
- Studies on special population (PMS, Old age (>45 years))
- Extensive cardiac monitoring studies
- First-to-file studies
- Rectal & Vaginal dosage forms
- Long acting injectables
- Studies with long washout and long housing
- A well established Glucose clamping facility with an experince in execution of more than 1500 clamps
- Experience in developing more than 800+ analytical methods which including complex and low sensitive molecules (Pg/mL)
- State-of-the-art large molecule analysis set-up and experienced work force for supporting of Large molecule analysis
- Team has successfully faced more than 50+ global regulatory audits (USFDA, EMEA, UKMHRA, ANVISA, GCC, TGA, Canada, MCC, NPRA, MOH Turkey) in their prior experience
- Digitalization of all study procedures from clinic initiation to report submission
- Report delivery in faster and quick turn around time
Our Differentiators
Experience
Team has over two decades of experience in handling various clinical research projects for global markets
Client Based Approach
Resource wise ready to cater for the ever expanding requirement(s) of clients
Technology Integration
Automation (online) of activities EDC, Data capturing & Analytical activities
Glucose Clamping
Team has experience in execution of handling 1500+ clamps
Global Presence
Collaborated with various global CROs to execute the study within interested geographic region
Project Management
Experienced project managers will be the single point of contact from initiation to closing of the project
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