Data Management

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Data Management

We have an indepth understanding of our sponsors because of our comprehensive clinical trial services history. The nature of our services requires us to be dedicated to quality, preciseness, and efficiency. Our knowledge and experience allow us to evaluate data requirements of each trial according to its own merits and compliance with each protocol.

Our team will help you to:

  • Prepare the overall plan, database and forms
  • Gather data over the course of the study.
  • Confirm that the plan, tools, and data meet the requirements, including data quality.
  • Monitor for issues or risks.
  • Protect the integrity of collected data
  • Map different datasets and information together in a cohesive, consistent format.
  • Review data to identify trends and report outcomes.
  • Secure the database and prevent changes to protect data integrity.

Risk-Proof Results

Quality and risk management are embedded into every step of the process, with our technology-enabled model facilitating early detection of risks and issues, feeding vital information to the project team and providing an adaptive approach to monitoring and trial delivery.

Flexible Model

With our support, sponsors meet their data management goals by coordinating their internal teams with our experienced data and project management teams We provide the flexibility needed to adapt to each sponsor’s specific requirements within the jointly developed quality assurance system. We have the flexibility to scale up or down if needed.

Collaborative Approach

We drive toward continuous improvement in quality, innovation and efficiency while capitalizing on best practices and lessons learned through our data and project management teams.

We have expertise in sponsors’ processes, procedures, and systems, adhere to standard practices, and perform to specified Standard Operation Procedures (SOPs).

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Secure and Rapid Decision Making

From data entry to database lock, we use latest techniques to identify and resolve data discrepancies and assure data quality. This results in the delivery of clean, reliable data to support rapid decision making and regulatory submissions while always ensuring consistent, on-time delivery.

By integrating our own systems and tools with Microsoft Azure Cloud, we have enabled our sponsors and investigators to view and utilize results securely and efficiently.

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Experienced Teams in all phases of clinical trials

Our data management services are delivered standard operating procedures designed around the framework of our SOPs.

Our teams work across the diverse requirements of all therapeutic areas, indications and clinical trial phases, with a team of project and data managers to identify best database design.

We work across all medical teams at the sites, sponsors, and internal project teams to deliver quality data on time.

Our team is comprised of experienced, dedicated, flexible, and accountable problem-solvers who ensure delivery of successful, compliant, and reliable results.

Helios EDC the Biggest Driving Force

Helios is the biggest and innovative driving force behind our data management system

We are able to identify problems pro-actively by focusing on emerging technologies, adherence to regulatory issues and protocols, implementing continuous process improvements and sharing best practices with our sponsors.

We specialize in clinical trials to accommodate project and data management service needs by offering industry-specialized Helios EDC to the sites and our sponsors.

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