Effective Pharmacovigilance and Clinical Trials process management is crucial to eliminate safety issues. While technology has advanced, OnBase offers a fully R3 compliant software that aims to capture, manage, and report on cases from one single platform.
OnBase is designed to capture data from applicant and trial approval forms, while securely managing these forms through a structured automated workflow process. PV audits can become seamless and efficient as OnBase allows secure access to critical data, all controlled by user access profiles.
OnBase also offers the solution to multiple siloed systems which require rework and manual entry from multiple sources.
Current challenges being faced within pharmacovigilance include:
- Accessing critical case documentation and information
- Inconsistency of information leading to difficulty in Monitoring process
- Manual data intensive processes which reduces efficiency and leads to error
- Difficulty Maintaining unified and accessible records in a secure manner
- Challenges in Preserving a process audit trail
- Regulatory compliance challenges
Implementing the OnBase PV Case Management Solution your organisation can realise the following benefits:
- Improve process efficiency and reduce operational costs
- Maintain quality and compliance requirements
- Provide transparency and accessibility to data bolstering public trust and confidence
- Provides access to literature knowledge bank
- Reduces redundancy by offering automated mailbox management and workflow automation
- Provides access to reporting and dashboards which provides
- Robust data analytical capabilities
- Ability to complete reconciliations
- Will provide for predication of emerging safety signals