Panexcell Clinical Lab Private Limited
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
• Statistical Analysis
• Data Management
• Medical Writing
• Special Population Studies
• Proof of concept studies
• Phase I - Phase IV Clinical studies
• Disease prevalence and modality of the treatment
• Safety monitoring
• Therapeutic training
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.
Well experienced team of Biostatisticians & SAS Programmer. Experience in handling different crossover, Parallel, Partial replicate, Fully replicate, Steady state bioequivalence studies.
• Study design
• Sample Size Calculation
• 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
• 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.
|Sales markets||Western Europe; Eastern Europe; Middle East; Asia; Australia; North America; Africa; Central/South America|
|Primary business activity||Service|
CPhI Worldwide 20195-7 November 2019 Frankfurt, Germany We were at stand 121B55 See our Exhibitor Profile See full Exhibitor List
CPHI Middle East & Africa 201916 -18 September 2019 ADNEC, Abu Dhabi, UAE We were at stand Q60 See our Exhibitor Profile See full Exhibitor List
Our Top products
Panexcell Clinical Lab Private Limited provides wide range of services which includes Bioanalytical Services. The Panexcell’s excellence is amply demonstrated by the in-house analytical method development, method validation and completion of subject analysis for a wide range of molecules. Contact us for more ...More info
Panexcell Clinical Lab Private Limited provides wide range of services which includes Clinical Services. It offers start to end GCP compliant clinical service beginning with screening of volunteers and their selection, applying strict inclusion and exclusion criteria as per DCGI / ICH –GCP / USFDA guidelines....More info
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