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
• 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.

Location: 

Contact details

R-374, TTC MIDC, Rabale,
400701
Navi Mumbai
India