Data Management & Statistics

MEDIcept Data Management provides expert, adaptable solutions for any clinical trial and Electronic Data Capture (EDC), Electronic Patient Reported Outcomes (ePRO), and IxRS platforms with high data quality.
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The MEDIcept Clinical Data Management team has hands-on experience with several data management systems, including Medidata RAVE, Medrio, OpenClinica, ClinTrial, IBM Clinical, and many others.

Our Data Management professionals are versed in conducting all aspects of a clinical study, including:

  • Case Report Form (CRF) design
  • Data Management plan
  • Database build and validation
  • Establish clinical trial data collection tools
  • Data processing, review, and cleaning
  • Query resolution
  • Data imports/exports
  • Study status reporting and metrics
  • Integration with other existing systems and processes (such as imaging and laboratories)
  • Reconciliation of external data
  • Establish enrollment and randomization systems study-specific
  • Establish CDASH standard datasets
  • MedDRA and WHODrug coding
  • Database maintenance and Archival

We are committed to providing the highest quality data with integrity and on the timelines for your study.

Biostatistics is required for any investigational product intended to determine the safety, efficacy, and effectiveness in a clinical trial.

The biostatistics involvement for any sound clinical trial starts with the study design to determine the appropriate statistical sample size calculation, the appropriate method for most effective endpoint determination, the data collection points, analysis, and reporting of the data collected during the course of the study.

MEDIcept provides full-service biometrics and biostatistical analysis services. Using tailored statistical methods, our team ensures robust analysis. MEDIcept has biostatisticians who are experts in device and pharma, as well as SAS programmers and validators who can program based on your trial needs with impeccable data integrity.

MEDIcept biostatistics can offer end-to-end services:

  • Study design sample calculation and protocol development of endpoints
  • Statistical analysis plan that meets International Council for Harmonisation (ICH E6)
  • Randomization Plans
  • Adaptive design and study execution support for missing data
  • SAS Programing support (ADaM, SDTM, etc.)
  • Database and TFL production to CDISC standards
  • DMC/DSMB reports, if needed for the study
  • Extensive quality control (QC) for production and validation programming
  • Results and statistical assessment review
  • Assistance to any regulatory authority submissions (attending and reviewing)

MEDIcept can provide data management and biostatistical support whether you engage with us for full-service CRO or for standalone services.

I need help NOW!

Have you received an FDA 483 notice or a warning letter? Are you struggling to meet new EU MDR or EU IVDR regs? We can help you respond quickly and effectively to help prevent a difficult situation from getting worse.

Need FDA or EU MDR/IVDR audit assistance?

Don’t go it alone. Our deep, firsthand experience with FDA and EU MDR/IVDR audits can help you minimize risk and business disruption.

Are you a start-up?

We’ve helped a wide range of start-ups develop effective regulatory strategies to obtain FDA and EU MDR clearances. We’ll work with you to develop an appropriate domestic or global regulatory strategy to help ensure compliance and product approvals.