Executive Summary

The clinical research landscape is undergoing rapid transformation, driven by increasing protocol complexity, decentralized and hybrid trial models, heightened regulatory scrutiny, and growing pressure to reduce development timelines. Amid these changes, study startup efficiency has become a critical success factor. One of the most significant contributors to startup delays is the study build process within Electronic Data Capture (EDC) systems.

Traditional EDC implementations rely heavily on customized development for each study, resulting in long build cycles, high costs, and increased operational risk. As portfolios expand and timelines compress, this approach is no longer sustainable.

This whitepaper examines how configurable EDC platforms enable organizations to streamline study builds and accelerate deployment. By leveraging standardized, reusable, and pre-validated components, sponsors and CROs can significantly reduce time to First Patient In (FPI), improve data quality, and enhance operational scalability, without compromising flexibility or compliance.

Introduction

Electronic Data Capture systems are critical to modern clinical trials, serving as the primary mechanism for collecting, validating, and managing clinical data. The effectiveness of an EDC system is not solely determined by its functionality but also by how quickly and accurately it can be configured to support a specific protocol.

Historically, study builds have been treated as one-off projects, with unique specifications, custom coding, and extensive testing for each trial. While this approach allows for maximum customization, it introduces inefficiencies that become magnified across large development programs.

As the industry moves toward:

• Faster study startups

• Adaptive and complex trial designs

• Increased use of real-world and decentralized data

• Portfolio-level standardization

there is a growing need for EDC solutions that prioritize speed, reuse, and configurability.

The Study Build Challenge in Traditional EDC Models

Lengthy and Resource-Intensive Builds

Traditional EDC study builds often involve:

• Detailed functional specifications

• Custom CRF development

• Hard-coded edit checks and visit logic

• Multiple cycles of development and testing

These steps can take several weeks or months, delaying critical milestones such as UAT, site activation, and FPI.

High Dependence on Specialized Technical Skills

Custom EDC builds require experienced programmers and system architects. When multiple studies run in parallel, these resources become bottlenecks, increasing risk and reducing predictability.

Limited Reusability

Despite similarities across protocols, custom-built studies rarely allow for seamless reuse. Even small differences often require reprogramming, leading to duplicated effort and inefficiencies.

Increased Risk of Errors and Rework

Manual coding increases the likelihood of defects in:

• Edit checks

• Visit schedules

• Conditional logic

• Derivations

These issues frequently surface late in UAT or after go-live, resulting in costly rework and data cleaning.

The Shift Toward Configurable EDC Platforms

What Is Configurable EDC?

A configurable EDC platform enables study teams to assemble studies using parameter-driven components rather than custom code. Configuration focuses on selecting, adjusting, and combining predefined elements to meet protocol requirements.

Key principles include:

• “Build once, reuse many times”

• Low-code or no-code configuration

• Modular and library-driven design

• Standardized data and workflows

  
  

Configuration vs. Customization

Configurable EDC does not eliminate flexibility, it channels flexibility through controlled, validated options.

Core Components Enabling Faster Study Deployment

Standardized CRF and Visit Libraries

Configurable EDC platforms maintain libraries of:

• Standard CRFs aligned to CDISC standards

• Common therapeutic area forms

• Reusable visit schedules

These libraries allow study teams to rapidly assemble a study by selecting pre-approved components instead of designing from scratch.

Parameterized Edit Checks and Validation

Rather than writing custom logic, edit checks are defined using configurable rules (e.g., ranges, dependencies, conditional logic). This reduces development effort and simplifies updates during protocol amendments.

Modular Study Architecture

Studies are built using logical modules such as:

• Screening and eligibility

• Randomization and dosing

• Safety and adverse events

• Efficacy assessments

Modules can be reused, added, or removed as needed, supporting both simple and complex protocols.

Pre-Validated Templates and Workflows

Reusable templates are validated once and deployed across multiple studies, significantly reducing repetitive validation activities while maintaining compliance with GxP and 21 CFR Part 11 requirements.

Operational and Business Benefits

Accelerated Study Startup

Configurable EDC implementations can reduce study build timelines by 30–60%, enabling faster:

• UAT completion

• Site activation

• First Patient In

  
  

Cost Efficiency

Reduced reliance on custom development lowers:

• Programming costs

• Validation effort

• Rework due to defects

Organizations can redirect resources toward higher-value activities such as data review and analytics.

Improved Data Quality and Consistency

Standardized forms and rules lead to:

• Fewer discrepancies

• Cleaner datasets

• Easier cross-study analysis

This consistency is especially valuable for integrated summaries and submissions.

Greater Agility During Protocol Amendments

Configurable systems enable quicker updates without extensive redevelopment, supporting adaptive trial designs and regulatory-driven changes.

Stakeholder Impact

Sponsors

• Faster time to market

• Improved oversight across portfolios

• Better scalability for global programs

  
  

CROs

• Increased study throughput

• Predictable delivery timelines

• Competitive differentiation

  
  

Clinical Operations and Data Management

• Reduced manual effort

• Easier training and onboarding

• Greater confidence in system quality

  
  

Regulatory and Compliance Considerations

Configurable EDC platforms are designed with compliance in mind, offering:

• Full audit trails

• Role-based access controls

• Version control and traceability

• Support for validation documentation

By reusing validated components, organizations can maintain regulatory rigor while accelerating deployment.

Implementation Strategy and Best Practices

Successful adoption of configurable EDC requires:

• Strong governance of standards and libraries

• Alignment with CDISC and internal data standards

• Change management and training

• A phased rollout starting with high-volume study types

Balancing standardization with flexibility is key to long-term success.

Future Outlook

As clinical trials increasingly incorporate decentralized elements, real-world data, and adaptive designs, the need for rapid, scalable EDC deployment will continue to grow. Configurable EDC platforms will evolve to support deeper integrations, advanced analytics, and AI-driven study optimization.

Conclusion

Streamlining study builds through configurable EDC platforms represents a strategic shift from custom development to intelligent configuration. By embracing standardized, reusable, and pre-validated components, organizations can dramatically reduce deployment timelines, improve data quality, and enhance operational efficiency.

Configurable EDC is no longer optional, it is a critical enabler of faster, more agile clinical research.

DISTILL EDC can reduce time and budget by more than 50% compared to traditional EDC systems.

For further information, please contact us at enquiry@svmpharma.com