Data Management

End‑to‑end clinical data management and biostatistics ensuring accuracy, compliance, and high‑quality.

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Data Management

Meet our experts

Our Data Management services span the data life cycle from collection to archive using regulatory-compliant tools that ensure data integrity and adherence to industry standards. Our experienced, agile and cohesive team of clinical data managers ensure a seamless flow from first-patient-in to database lock. Close collaboration with our biostatistics team guarantees the timely delivery of accurate, high-quality study results.

  • Proactive data quality strategy implemented from database build
  • Efficient data cleaning and review workflows to support timely database lock
  • Integration of external data sources into a consistent clinical database
  • Delivery of reliable datasets for statistical analysis and regulatory submission
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Core Data Management Services Include

Quality and Regulatory Compliance

Ensuring all data management activities follow SOPs, Good Clinical Practice (GCP), and regulatory requirements, supporting audit  

eCRF Design and Database Build

Creating optimised eCRFs and study databases tailored to the protocol and data collection requirements

Data Validation and Edit Checks

Implementing automated and manual checks to identify inconsistencies and ensure data accuracy

Query Management & Ongoing Data Review and Cleaning

Handling data discrepancies and queries to maintain completeness and correctness of the dataset 

External Data Integration

Reconciliation and integration of vendor-supplied data into the clinical database.

CDISC and Regulatory Readiness

Structuring data to comply with industry standards (e.g., SDTM) and regulatory requirements
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End-to-end Data Management

eCRF design, EDC/database management, query handling, data validation, third-party/vendor data integration, medical coding, safety reconciliation, and database lock.

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Regulatory Alignment

Compliance with ICH GCP, FDA, EMA, and PMDA guidance, validated system processes (GAMP4/GAMP5), SOPs, and industry best practices (CDISC, SCDM, ACDM), safeguarding data integrity, traceability, and regulatory acceptability. 

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CDISC Expertise

SDTM dataset structuring to ensure consistent, standardized datasets that serve as the foundation for downstream ADaM programming and statistical analysis.  
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Technology Stack

ViedocTM, SAS, Pinnacle21 Enterprise and other validated EDC and data management tools.

Case Study: Accelerated Database Lock and Submission Package Delivery

The Challenge

The sponsor needed to achieve a rapid, high‑quality database lock following study completion while managing multiple data streams and avoiding the typical end‑of‑study backlog. This included coordinating timely third‑party data integration, medical coding, and safety reconciliation, all of which can delay database lock if left until the end of the trial. Ensuring data quality and alignment across internal and external sources—without compromising regulatory readiness—was critical to meeting aggressive timelines.

Sponsor Outcome

 A proactive data review approach enabled soft database lock within three weeks of LPLV, with third‑party data, medical coding, and safety reconciliation already completed.

Continuous data cleaning and regular vendor data integration throughout the study ensured the database was largely clean at study close, avoiding typical end‑of‑study delays.

This enabled final eCRF hard lock in under six weeks post‑LSLV, with the final SDTM submission‑ready package delivered within one week of unblinding.

Sectors We Work With

Start -ups and academics

Benefit from flexible support, scalable Data Management systems, and guidance in establishing robust data collection and data quality processes from study start to database lock.  

Biotech companies

Gain specialist expertise in designing efficient eCRFs, managing complex data flows, and ensuring high-quality data throughout early or late phase studies.

Pharma sponsors

Receive robust, compliant Data Management processes aligned with global regulatory expectations and industry data standards.

Why Consider hVIVO

As part of a full-service early-phase CRO, hVIVO unites Data Management and Biostatistics with laboratory, PK/PD, clinical operations, and medical writing teams. 
This integration reduces timelines, eliminates vendor complexity, and ensures scientific consistency from study build to submission. 

Statistics

By offering tailored solutions with a strong focus on quality, our clients can stick to timelines and keep costs to a minimum. Our statisticians provide statistical support along the full development cycle of the drug, from early development to post-marketing studies, across a wide variety of therapeutic areas.

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Project Management

We provide comprehensive, agile clinical trial management services designed to transform your clinical trial’s potential into measurable success. From small biotechnology firms to large global pharmaceutical companies, our experienced team offers customised support to advance your development plans.

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Drug Development Consulting

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Recruitment

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Medical Writing

Scientifically rigorous, reviewer-friendly medical writing to help life science teams deliver clear, consistent documentation across clinical development and regulatory milestones. 

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FAQ

Get in touch with us

 We comply with CDASH/SDTM (CDISC) standards, ICH guidance's, EMA and FDA guidance's as appropriate.  

Yes — services can be contracted independently or as part of a full clinical service package.  
We utilise ViedocTM for EDC, SAS® 9.4, and Pinnacle21® Enterprise for CDISC validation. We have also the capability to use any other EDC systems. 
 Yes — our team has deep experience in  early phase  and adaptive designs across diverse therapeutic areas.  
Yes — our team has a strong experience also in later phases, including Phase III and IV as well as Non-Interventional Studies. 

Contact Our Data Management Team

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