Biostatistics Services

Clinquest offers the following biostatistics services:

  • Statistical Consultancy
  • Randomization services
  • Sample size calculation / Power calculation
  • Writing Statistical Paragraph in the Protocol
  • Writing Statistical Analysis Plan (SAP)
  • Programming and Performance of Statistical Analysis
  • Performance of Interim Statistical Analysis
  • Statistical Report Writing
  • Writing Method and Result Section of Scientific Papers

We can also assist you in all stages of your clinical study, not just the statistical analyses. Let our statisticians assist you during the start-up phase of your program. We can provide advice on study design, choice of endpoints, hypothesis composition, and number of subjects needed for the required power.

Biostatisical Services Plan: Step by Step

Our statistical analyses are performed using industry standard SAS software, and our GCP-compliant SOPs guarantee high quality results. Your results are presented in a statistical report describing the analyses performed and include an interpretation of the results.

Sample Size and Power Calculations:

How many subjects are needed for your study? This is a key question, as not enough subjects can mean the uncertainty margins in the statistical analyses are too large to confirm your hypotheses. We can calculate the number of subjects necessary to provide the statistical power required for the level of accuracy you need for your study.

Statistical Writing for Protocols:

We can write or review the statistical section of your Clinical Research protocol. Our staff understands the importance of selecting appropriate primary (and secondary) endpoints, and will prepare the planned statistical methods, statistical power, and sample size for your protocols.

Randomization Services:

Clinquest can create randomization lists for a variety of designs and provide blinded, sealed envelopes with randomization codes.

Statistical Analysis Plan (SAP):

Although similar to the statistical content of the protocol, the SAP is an all-inclusive document detailing the statistical management of your project. Our SAPs contain detailed descriptions of the statistical methodology of planned analyses, of checks of assumptions made in the analyses, of planned data transformations, and of use of covariates. The SAP also documents how missing data will be handled, which analysis populations will be used (e.g. Intent To Treat (ITT), Per Protocol (PP)), and contains shells for all of your data listings, tables and figures.

Programming for Statistical Analysis:

After completion and approval of the SAP, statistical programming begins. Our staff finalizes all programming before database lock to ensure objectivity.

Validation of SAS Programs:

For Phase I, II and III clinical studies, primary endpoint analyses are independently programmed by a second statistician. Additional validation steps are identified when necessary, in collaboration with the client, and validated SAS macros are used in the analyses.

Quality Control (QC):

All steps in the statistical process (e.g. sample size calculation, SAP, statistical report) are reviewed by a colleague statistician. Datasets provided by the Data Management System or delivered by a third party undergo a QC review to ensure that the process of exporting data and loading data into SAS is error free.

Blind Review:

Prior to unblinding data and performing the final statistical analysis, a blind review will be performed to assess the Per-Protocol Analysis Population, in accordance with the client’s specifications. Our staff can also prepare Interim blinded safety reports for Data Safety Boards.

Unblinding Data:

Only at the time of final analysis are randomization codes imported to indicate the actual treatment of subjects. This unblinding procedure is performed by two staff members and is then checked for accuracy.

Final Statistical Analysis:

After data base lock, final SAS datasets are retrieved from the database. The validated Statistical Programs are run to prepare listings, tables, and figures. A QC review of the final results is then performed to ensure accuracy. Results are delivered in Word or PDF format.

Interim Statistical Analysis:

Our staff can perform interim statistical analyses prior to database lock. We can also provide unblinded interim results while keeping the client blinded when necessary.

Writing Statistical Report:

After completion of the analysis, our statistician will write a detailed statistical report describing the statistical methods used and a statistical interpretation of the results. The statistical report is sent to the client for approval, and our medical writer can incorporate the results into the final clinical report.