Panexcell Clinical Lab Private Limited

Panexcell Clinical Lab Private Limited

About

Company description


Panexcell
is a well-established BA/BE centre at Mumbai, INDIA with total Bed Capacity of 58 and 21 CFR, Part 11 compliant sophisticated instruments like LCMS - API 5500.

Panexcell
have a comprehensive total quality management systems, standard processes specifically designed for high-quality deliverables, a sustained and reliable regulatory environment, and highly trained manpower.

Services Offered in BA/BE:

• Bio-Availability / Bio-Equivalence  Studies
• Pharmacokinetic Studies with NDDS and NCEs
• Bio-analytical
• Statistical Analysis
• Data Management
• Medical Writing
• Special Population Studies

Clinical Trials:

• Proof of concept studies
• Phase I - Phase IV Clinical studies
• Disease prevalence and modality of the treatment
• Safety monitoring
• Pharmacovigilance
• Therapeutic training 

Medical Writing:

Our Medical writing team supports the planning and conduct of studies with utmost focus on safety. Their role comprises protocol designing, interacting with key operation leaders in specific therapeutic areas to obtain their inputs on study design for scientific as well as partial implications. Report writing as per ICH E3 format. The team has extensive experience in evaluating the eligibility of the volunteers, management of SAEs across all key therapeutic areas and reporting AEs as per regulatory requirements.

Bio statistics:
Well experienced team of Biostatisticians  & SAS Programmer. Experience in handling different crossover, Parallel, Partial replicate, Fully replicate, Steady state bioequivalence studies.

Services offered
:
• Study design
• Sample Size Calculation
• Randomization
• Statistical Analysis Plan
• Interim Analysis and Data Monitoring
• Statistical Data Analysis (Efficacy and safety assessment)
• Statistical Inference & Interpretation Outputs and data sets as per CDISC Standard

Data Management

• Panexcell offers comprehensive Clinical Data Management (CDM) services in adherence to CFR Part 11, regulatory and project specific requirements.
• Our CDM team comprises highly skilled and experienced team members, who have worked with complex therapeutics areas.
• CDM team works with the objective to deliver high quality data on time to achieve client’s expectations and to advance the process of regulatory submission.

Quick facts

Sales markets Western Europe; Eastern Europe; Middle East; Asia; Australia; North America; Africa; Central/South America
Primary business activity Service

Upcoming events

16 sep 2019

CPHI Middle East & Africa 2019

16 -18 September 2019 ADNEC, Abu Dhabi, UAE Visit us at stand Q60 Book a meeting See our Exhibitor Profile   See full Exhibitor List
5 nov 2019

CPhI Worldwide 2019

5-7 November 2019 Frankfurt, Germany Visit us at stand 121B55 Book a meeting See our Exhibitor Profile   See full Exhibitor List

Recently at

18 jun 2019

CPhI & PMEC China 2019

18 - 20 June 2019 SNIEC, Shanghai, China We were at stand E1N37 See our Exhibitor Profile   See full Exhibitor List
12 dec 2018

CPhI & PMEC India 2018

12-14 December 2018 India Expo Centre, Greater Noida, Delhi NCR We were at stand 17.A07 See our Exhibitor Profile   See full Exhibitor List
9 oct 2018

CPhI Worldwide 2018

9 - 11 October 2018 Madrid, Spain We were at stand 3A52 See our Exhibitor Profile   See full Exhibitor List