Data Management & Statistics

Data Management & Statistics

At ProRelix Research we are a team of experienced people who are well aware of 21 CFR, HIPAA, ICH GCP compliance to provide clinical data management services. Our statisticians have extensive experience in various phases of clinical trials and different therapeutic areas. Working on a project, our team sees each study through from protocol and CRF design to statistical report.

  • Perform data management (Study Set Up) activities

  • CRF Designing/Tracking

  • Test script and UAT

  • Data Entry and Verification Data Review/Query Generation

  • Discrepancy Resolution

  • Preparation of mock CRF, CRF completion Guidelines (CCG)

  • Preparation Data Validation Specifications (DVS), Study – Plan Specifications (SPS) etc

  • Statistical Analysis per Protocol

  • Final Trial Reporting

PRORELIX RESARCH provides traditional clinical data management solutions as well as an Electronic Data Capture (EDC) and Electronic Patient Reported Outcomes (ePRO) approach, giving flexibility in data management solutions while always maintaining high standards for data quality and timeliness.

In addition to full-service clinical research trials, PRORELIX RESEARCH supports many stand-alone and functionally-based biometrics projects. Clients rely exclusively on our staff to manage all biometrics aspects from rapid data entry to final trial reports. Our experience allows us to make recommendations on the most efficient and cost-effective approach for any clinical research trial.

The PRORELIX RESEARCH Clinical Data Management team has built up extensive hands-on experience with several data management systems over the past years. Therefore, our Data Management team is able to offer our clients the right solution for their project.

As a result and similar to all other areas of our operations, PRORELIX RESEARCH is able to offer the flexibility that our clients desire and require.

Often our clients require PRORELIX RESEARCH to manage all Biostatistics aspects of their projects from protocol development and sample size calculation to final study report. Our experience allows us to identify the most efficient and cost-effective approach to completing your clinical trial.

The PRORELIX RESEARCH philosophy is always to leverage our experience and expertise to support each and every client regardless of their size or project scope. This philosophy ensures each and every assignment receives the same dedication, ownership, and team.

PRORELIX RESEARCH Provides the Following Biostatistics Services

Consulting

  • Regulatory interaction – FDA/ICH/EMA and advice (including CDISC integration)

  • Process improvement

  • Statistical support on-site

Design

  • Sample size calculations

  • Randomization

  • Protocol development and clinical study planning

  • Statistical analysis plan (SAP)

  • Presentations of study design to regulatory agencies

Enquire Now