Biostatistics and Data Management

For clinical data management, electronic data capture and biostatistics services, count on SPRI Clinical Trials. Our experienced teams and strategic partners are committed to increasing efficiency and quality to ensure the success of your trial.

Clinical Data Management

Data management can optimize your clinical EDC experience. SPRI’s data management teams play a key role in:

  • Generating annotated case report forms (CRFs)
  • Providing eCRF completion guidelines
  • Generating transfer data specifications
  • Data review (query generation, review and resolution)
  • Medical coding (adverse events and conmeds)
  • SAE reconciliation with safety database
  • Imports and exports from outside sources

Electronic Data Capture (EDC)

A clinical trial is only as strong as the data it generates. At SPRI, our team believes that quality data allows for a clean database that can be closed quickly. As clinical EDC becomes commonplace in our industry, our teams have become experts on a number of EDC systems.

While SPRI’s clinical data management teams are proficient in all the major EDC systems, we have chosen three that are CDISC, CDASH and STDM compliant and have worked with providers of our chosen EDC systems to integrate their processes in our workflow.

Many clinical research sponsors develop their eCRFs and data transfer standards during their first Phase I trial and continue these standards through Phase II and Phase III. It is with this understanding that SPRI has chosen not to standardize on one clinical trial EDC platform but to instead broaden our experience and knowledge base in order to meet the needs of our clients.

Clinical Biostatistics

SPRI partners with an experienced team of clinical statisticians who have the therapeutic experience to provide you with the support you need.

As clinical trials and regulations become more complex, it is important to work with a biostatistician who understands the current regulatory environment. At SPRI, we pride ourselves on matching the needs of our clients with the appropriate statistician or stats team.

SPRI partners with experienced professionals to provide the following clinical biostatistics services:

  • Trial design
  • Sample size determination
  • Statistical analysis plan
  • Randomization management
  • Blinded review
  • SAS tables, figures and listings
  • DSMB support

Interested in learning more about SPRI’s biometrics solutions? Contact us today to discuss your needs. With strategic offices in the United States (New York and North Carolina), Ukraine, Russia, Georgia and Belarus and strategic partnerships in Western Europe and Australasia, SPRI Clinical Trials is uniquely positioned to meet the clinical biometrics needs of global clinical research studies.