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Data Management & Biostatistics

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QED offers a unique mix of high-quality, innovative data management and communication solutions, leveraging high-end technology and clinical trial expertise to help Sponsor’s process and produce data faster and at lower cost, whether the original input is paper or electronic (EDC).

The result is a fully compliant, standardised methodology for processing, validating and presenting real-time information to clinical trial managers and monitors. QED’s experience in clinical trials combined with the technology built into ClinCAPT – our data management platform – act together in providing a number of critical advantages, not only by shortening process time while improving process control and flexibility, but also by substantially reducing data processing costs.

From design and printing of case report forms through data entry and cleaning, QED’s Data Management services are highly flexible, streamlined and efficient. Our internal systems can integrate and convert database formats to make sure that all data are provided, as required. Coding services using MedDRA, WHOart and WHODrug are also available.

QED’s centralized clinical trial data management environment provides a compliant and standardized methodology for processing, validating and presenting real-time information to clinical trial managers and monitors.

Furthermore, QED apply Quality Control measures to all aspects of the Data Management process − including study set-up, active processing and database lock. All activities are conducted strictly according to Sponsor’s or QED’s SOPs.

The Technology Platform

ClinCAPT is an innovative integrated Capture and Data Management System that collects data in a wide range of formats with robust data management functionality − reducing data reconciliation errors and allowing real-time access to clean clinical data.

Using powerful imaging and connectivity tools, ClinCAPT integrates all clinical data − including electronic CRF (EDC), paper (Double data entry and/or OCR) and fax-based input, laboratory data, IVRS and many more − into a single electronic file. Designed to comply with high-level regulatory requirements, ClinCAPT operates in a fully secure environment and exports to SAS and CDISC formats.

Extremely flexible, quick to set up, and 100% accurate, ClinCAPT saves significant time and money.

eCRF Services

ClinCAPT allows comprehensive services for eCRF.  The data can be captured in HTML or in PDF format. Being similar to the paper CRF, the latter is particularly well accepted by investigators. In addition, it allows for the conduct of “hybrid studies” in a totally transparent way.

The queries, according to their complexity, are either run on-line or off-line in the database with involvement of the data managers.

CRF Viewer

The completed CRF – whether manually or electronically filled in – is available as an electronic image throughout the entire process. The availability of the CRF in a PDF document with all navigation possibilities makes consultation extremely easy and provides a highly useful management and monitoring tool.

Reporting Services

The ability to provide a variety of reporting tools is essential to meeting Sponsor’s specific requirements. QED’s reporting solutions span the key requirements for both clinical and trial performance data. Clinical data reports allows tracking of subject and site compliance and validation of data queries and follow-ups. Trial performance reports help identify bottlenecks and track performance issues throughout a trial’s duration.

Secure Internet Portal

QED’s Internet portal provides controlled, secure access to:

A vital link between all study participants, the portal is even more critical for EDC, as it provides the communication interface for investigators to enter and correct data and to manage their patients.

Hosting

QED’s secure state-of-the art data center has been engineered to exceed  customers’ expectations for globally accessible, highly reliable, secure and scalable application performance. The network and security requirements are very stringent, necessitating a robust infrastructure and staff with specialized expertise. Ensuring the appropriate Internet connectivity, load balancing, firewall requirements and meeting service level agreements are vital to deployment.

Statistics Services

QED Statistics services − from study design through the final integrated clinical report − are provided by our professionally trained Biostatisticians, who have extensive experience in statistical methods and programming techniques in applications across a broad range of therapeutic areas.

QED’s primary system for statistics and reporting is SAS©. Continual quality control measures − including peer review, double programming and internal audits of data samples − ensure that all of our services are of the highest caliber: