Data Management

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"Taking the right statistical approach is only half the battle – it is just as important to know what data to collect and how to database it."

 

Business & Decision Life Sciences provides industry leading clinical data management services and solutions, collecting, cleansing, analyzing and preparing clinical data for regulatory submission, within the timescales needed to meet tight project deadlines. 

We understand how best to manage your data. We ensure that only reportable data are collected and managed in a way that complies fully with regulatory requirements.

We tailor our services to give you optimal results - we have our preferred methods and tools for collecting data but we are ready to use your systems if you prefer. The only things we will not compromise on are our quality standards that produce superior results and satisfied clients

Ever increasing time and budget constraints on the collection, cleansing, analysis and preparation of sponsors clinical data has changed the landscape in clinical data management. Business & Decision Life Sciences' experienced team of data managers understands that clients need a high quality service tailored to their needs. Business & Decision Life Sciences undertakes the responsibility of assisting sponsors to meet their data management needs and:

  • Integrate with sponsor's study teams, and suggest solutions and improvements in the data management process
  • Provide a single point of contact for communication with the sponsor, and provide a dedicated team for each project
  • Provide flexible data collection options, including connections to sponsor's data management systems and RDC (EDC) providers
  • Perform data management in a regulatory compliant manner and use tested, robust standard operating procedures

 

Data Management Solutions and Standards

Data management planning

We produce well-defined, tailored Data Management Plans (DMPs) for effective project management and timely delivery of clean databases.

 

Study start-up

We get studies off to the best possible start, whether using an EDC or paper-based system. Logical CRF design, rapid clinical database build and deployment, and quality edit check programming all expedite project start-up.

 

Data collection

Capturing the data can be completed through traditional paper based methods or via the utilisation of Electronic Data Capture (EDC) to enable edit-checking and discrepancy management, to reduce costs and delays.

 

Core data management

Throughout the study we proactively manage the data, including edit-checking and discrepancy management, to reduce costs and delays.

 

Centralised data monitoring

Through centralised data monitoring we can identify missing data, perform consistency checks, verify source data and identify screen failure rates. This reduces the need for costly site visits.

 

Medical coding and medical data review

We offer both manual and automatic coding. Our processes ensure minimal variability in data reporting and analysis to achieve better reconciliation between safety and clinical databases, and consistent use of dictionaries.

 

Quality control

By applying our rigorous QC standards, we ensure robust data quality to underpin study findings and meet regulatory requirements.

 

Output of data to industry standards

With proven data conversion skills, Business & Decision Life Sciences offers a unique additional service which is not common in most classical CROs. As a standard service, Business & Decision Life Sciences' team can receive any type of data, and regardless of the content or structure can deliver your database package ‘eCTD ready' in the current CDISC SDTM standards:

  • The CDISC SDTM annotated CRF, including bookmarks
  • The CDISC SDTM datasets
  • The define.xml or CRT-DDS metadata
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