Late Phase Trials

eProtocol – Electronic Protocol Management

eProtocol is a structured Electronic Protocol Management solution designed to digitise, standardise, and operationalise clinical trial protocols for late-phase studies. By converting static protocol documents into dynamic, actionable workflows, eProtocol enables accurate interpretation of protocol requirements, reduces ambiguity, and ensures consistent protocol execution across sites, countries, and study teams.

Key Benefits

1

Protocol Clarity

Improves understanding of protocol requirements by presenting them in a structured, actionable format.

2

Error Reduction

Reduces protocol misinterpretation and operational errors at sites.

3

Faster Amendments

Accelerates rollout and adoption of protocol amendments across global studies.

4

Execution Consistency

Ensures consistent protocol execution across sites, countries, and study teams.

5

Deviation Prevention

Lowers the risk of protocol deviations and associated rework.

6

Regulatory Compliance

Supports strong compliance with regulatory and inspection expectations through traceable protocols.

Services Section

Key Functionalities

Protocol Authoring
Centralises the creation and management of clinical trial protocols to ensure accuracy and consistency.
Structured Breakdown
Breaks protocols into section-wise, structured components for clear interpretation and execution.
Role-Based Access
Provides controlled access for sponsors, CROs, investigators, and reviewers based on defined roles.
Version Control
Manages protocol versions and amendment history to maintain full traceability.
Amendment Distribution
Automatically distributes protocol updates and amendments across sites and connected systems.
Workflow Linkage
Links protocol guidance directly to downstream trial workflows to support operational execution.
Impact Visibility
Highlights the operational impact of protocol amendments to support timely adoption.
Audit Trails
Maintains complete, time-stamped audit records for all protocol changes and actions.
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reduction in protocol-related operational queries

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faster rollout of protocol amendments across sites

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decrease in protocol interpretation errors at sites

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auditable protocol versions with complete change history

Let's understand how you manage your Late Phase Studies?