Every statistical result is only as good as the data under it. Our clinical data management team looks after that foundation. We work with sponsors, CROs and study teams to collect data accurately, find problems early and keep the record clean and consistent until the database is locked.

We use risk-based, documented processes aligned with the protocol, applicable regulatory requirements and your own standards. The aim is simple: fewer surprises at lock, and less rework afterwards.

What we do

  • Study start-up and data management planning. We write data management plans, set out review procedures and define workflows that match the protocol and the timeline, so everyone knows how data will be handled before the first patient is enrolled.
  • CRF and eCRF design and review. Good forms capture what the protocol needs and nothing that will confuse a site. We design and review paper and electronic CRFs with data entry, review and downstream analysis in mind.
  • Clinical database build and validation. We support database design, configuration, testing and validation against approved specifications.
  • Edit check specification and validation. We specify checks that catch missing, inconsistent, out-of-range or contradictory data, and test that they behave as intended.
  • Data cleaning and query management. Systematic review, discrepancy identification, and query generation, tracking and follow-up with sites and study teams.
  • Medical coding. Coding of medical history, adverse events and concomitant medications using MedDRA and the WHO Drug Dictionary, with consistent term selection and documented review.
  • External data reconciliation. Checking data from laboratories, central imaging, ECG vendors and other third parties against the clinical database, and chasing differences to resolution.
  • SAE reconciliation. Reconciling serious adverse event data between the clinical and safety databases, so data management and pharmacovigilance are working from the same facts.
  • Data quality review and risk management. Structured reviews to find gaps, protocol deviations and threats to data integrity, and to help the team focus on the issues that matter most before lock.
  • Database lock and study close-out. Open query review, reconciliation checks, completion of data review, documented approvals, database closure and archival.
  • Submission and archival support. Preparing data management deliverables for analysis and submission, and organising records for retention in line with applicable requirements.

What you get

  • Complete study coverage from start-up through close-out, or just the activities you need.
  • Early visibility of data issues rather than last-minute lock delays.
  • Clear documentation and traceability.
  • Close coordination with investigators, safety teams and external data providers.
  • The option to buy by study, by activity or as an embedded team.
  • Tools and systems
  • Talk to us about your data management needs, from a single study to a full programme.