Clinical Applications

Clinical Applications

A plethora of technologies and the ever-increasing complexity, volume, regulatory requirements, and geographic spread of clinical trials is forcing companies to examine their core focus areas, while encouraging them to outsource clinical data management, SAS programming and bio-statistics to a trusted partner.
With the primary focus of a bio-pharmaceutical company or a CRO being science and research, they need a versatile technology organization with clinical research expertise to take care of all their data management, clinical programming and IT needs without incurring additional fixed costs. They also look for supporting partners who need to be responsive and can ramp up and down to meet the peaks and valleys of work load, at a reasonable cost while ensuring high quality working in regulated environments.

How Can Diligent Group Solutions Help?

Diligent Group provides flexible and scalable engagement models to manage your Bio-statistics and SAS Programming outsourcing needs. These models assure quality services, constant communication, improved efficiency at 15% – 40% cost savings.

Diligent Group has a wide range of expertise in all phases of clinical trials (I-IV), with all its statisticians and statistical programmers holding advanced degrees and having a strong exposure to various therapeutic areas. Diligent Group works with the end goal in mind, which is the timely submission of results from various clinical stages in order to support regulatory review, approval and monitoring of patient safety.

Products/Services

SAS Programming
Standardized approach for analysis files
Transportable tools to support standard non-efficacy reports
Programming based on analysis data
Independent quality reviews
Customized clinical data outputs
Proactive, results-oriented approach to programming
Programming for integrated summary of safety and efficacy
Adoption of sponsors programming (SOP) Preparation of Case Report Tabulations (CRT) for submission
Programming based on data validation plan
Programming of tables/listings/figures for clinical study report and data monitoring committee

Biostatistics

Consultation on study design
Protocol development
Randomization
Statistical Analysis Plan (SAP)
Interim analysis
DSMB participation
Sample size calculations