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Clinical Data Collection Services

Pubrica supports clinical data collection for trials, registries and observational studies. Clinical measurements, examination findings, diagnostic results and outcomes are recorded at site to the protocol, using case report forms with built-in checks, and monitored in line with Good Clinical Practice so that the dataset is complete and verifiable.

  • Protocol-driven case report forms, with edit checks and clear completion guidelines
  • Conducted in line with ICH E6(R3) GCP, with source documentation and monitoring
  • Trained site staff with training records kept for each role
  • Outcome adjudication by an independent committee where the protocol specifies it
  • Queries tracked to resolution before database lock
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What you receive

Locked clinical datasetIncluded

Case report forms and completion guidelinesIncluded

Monitoring and query resolution recordsIncluded

Data management plan and data dictionaryIncluded

Data-collection methods summaryIncluded

Service Scope

What Our Clinical Data Collection Service Covers

Each project is scoped individually. The components below are combined according to your study and its requirements.

Case report form design Paper or electronic CRFs designed to the protocol, with completion guidelines.
Vital signs and examinations Blood pressure, heart rate, temperature and examination findings recorded to standard procedures.
Diagnostic results ECG, imaging and laboratory results captured and reconciled with source documents.
Adverse event recording Adverse events recorded, coded and reported to the protocol and regulatory requirements.
Outcome adjudication Endpoint events reviewed against predefined criteria by an adjudication committee.
Monitoring and data management Source data verification, query management and database lock.

Applications

Studies That Use Clinical Data

Clinical trialsEfficacy and safety data across sites.
Disease registriesStandardised data on diagnosis, treatment and outcomes.
Observational cohortsClinical follow-up over time.
Medical device studiesPerformance and safety data.
Investigator-initiated studiesAcademic studies at one or more sites.

Process

How the Project Works

Methods, deliverables and fees are confirmed in writing before work begins.

01 Protocol reviewWe review the protocol, ethics approval and sample size, and identify the measures and the data standards required.
02 Tools and trainingCase report forms, measurement procedures and data-entry checks are prepared, and field staff are trained and assessed.
03 Collection and monitoringData are collected to protocol, with quality checks, query resolution and regular progress reports.
04 Cleaning and documentationThe dataset is cleaned and locked, with a data dictionary and a record of every correction.
05 HandoverYou receive the dataset, the documentation and a data-collection report suitable for the methods section.

FAQs

Frequently Asked Questions

If your question is not answered here, ask an expert.

Yes. Data collection is conducted in line with ICH E6(R3) and the requirements of the study’s ethics and regulatory approvals.

Yes. We build electronic CRFs, for example in REDCap, or work within the system your study already uses.

Qualified site staff trained on the protocol carry out clinical procedures, with training records kept for each role.

Where the protocol requires it, an independent committee reviews events against predefined criteria, blinded to treatment where applicable.

Pubrica Academy

Further Reading in Pubrica Academy

AcademyCommonly Used Medical Data Collection Approaches in Clinical Research AcademyPatient Data Management in Medical Data Collection AcademyObservational Clinical Study Designs CategoryAll articles in Research Data, Analytics & AIPubrica Academy articles on statistics, data collection, analytics and AI.

Request a Quote for Clinical Data Collection

Share your protocol or study outline. We confirm the setting, sample, measures, timeline and fee before fieldwork is planned.

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Regulations

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What do you need?

Material you send is held under signed confidentiality, with access limited to the assigned team and encrypted transfer. It is not used to train anything and is not passed to third-party tools. Ask for the agreement before you send anything you would rather cover first.