Industries We Serve – Qforce Pharma Consulting

Pharmaceutical and Bio-Pharmaceuticals

Pharmaceutical and biotech landscape has changed rapidly in the last few years. Organisations have to keep up-to-date with changing international regulations, supply chain issues, product/ process complexity. Qforce has extensive experience in interpreting the guidelines, formulating quality systems for increased efficiency, and driving business benefit by eliminating the risk of non-compliance.

Qforce is familiar with,

21 CFR Part 11 USFDA
TGA
MHRA
ICH
WHO

Clinical Research Organisations

Clinical Study Designing: Deciding of the Patient Population, Randomization and allocation of treatments, Calculation of Sample Size of the study, Simulation of Trials Data

Clinical Data Management: Designing eCRF, Defining the database, setting it up and validating, CRF tracking, registration and data entry (tracking double data entry), Creating a data validation plan, editing check programming, testing and validating the entries

Clinical Trials Analysis: Tables, Listings and Graphs generated, Creating randomization lists suited to the study and validating the randomization lists

Biostatistics: Sample size Calculation, Trial Simulations, Validation of Surrogate Endpoints

Data Consulting Services: CDISC Review and Gap Analysis, Management Dashboards

Medical Devices

The medical device manufacturing industry produces equipment designed to diagnose and treat patients within global healthcare systems. Medical devices range from simple tongue depressors and bandages to complex programmable pacemakers and sophisticated imaging systems.

We provide compliance services per 21 CFR 820, ISO 13485.