Services

Biostatistics and SAS Programming

Biostatistics is a critical element in clinical trials, regulatory submissions, and market promotion. Brightech supports this process by providing exceptional consulting services ranging from individual trial design to complete product development programs to support your clinical studies and regulatory submissions.

Brightech will work closely with your team to understand your specific requirements to build a comprehensive strategic plan to support your project needs.

Our highly trained staff of experienced statisticians have all earned a Ph.D. degree and our exceptional team of SAS programmers have earned a Ph.D. or MS degree. Brightech’s Biostatistical Team brings an average of 18 years of experience in study design, statistical analysis, SAS programming, clinical study reporting, NDA submissions, and FDA interactions. We have extensive experience in study design and analysis for diverse therapeutic areas, particularly oncology.

Whether you require our services as an integral part of a full clinical development program, or as a stand-alone market support service, Brightech can quickly deploy the right resources at the right time to meet your project timelines within budget. We are proud of our excellent track record serving over 25 long-term clients, meeting every timeline, and providing excellent quality and efficient services, resulting in high levels of client satisfaction.

Solutions

Statistics

• Trial design (including Group Sequential Design or Adaptive Design)

• Sample size estimation (including sample size re-estimation)

• Development of statistical analysis plan and report

• Development of integrated summary of efficacy and safety (ISE/ISS)

• Interim analysis and Data Monitoring Committee (DMC) support

• Statistical “helpdesk” for immediate consulting needs

• Publication support and market research

• Provide support and interaction with regulatory agencies

• Perform independent Quality Control (QC) analyses

• Provide patient registry support

• Provide post-marketing publication support

SAS Programming

• Generate Tables, Figures and Listings (TFLs)

• CDISC services: mapping specifications, SDTM/ADaM and define.pdf or defined.xml

• Generate customized patient profiles

• Programming support for Data Management

• Programming for annual safety report

• Generate pooled datasets and TFLs for ISE/ISS

GO BACK

Get a Callback

Fill in your details below and a member of our team will contact you promptly.

Submitting Form...

The server encountered an error.

Form received.