Clinical Trial Monitoring
Our skilled and well-trained clinical research associates (CRAs) ensure the highest quality review of data and effective interaction with study sites. Our clinical research associates conduct on-site monitoring visits throughout the study to:
- Oversee data collection
- Review source documentation and case report forms
- Ensure regulatory compliance
- Resolve data queries
- Conduct interim analyses as requested by clients
The Bio soft research is dedicated to employing and retaining well-qualified clinical research associates who:
- Have demonstrated site monitoring proficiency to our management before being allocated to a study
- Are typically dedicated to one protocol at a time to maintain quality
- In Europe and Asia, are assigned to monitor sites in their home countries, providing understanding of local languages, regulations, customs and business practices
Functional Service Provider (FSP)
The global expertise you need to ensure patient safety, data quality and protocol compliance
Bio Soft Research supports biopharmaceutical, biotech and medical device organizations through our bespoke clinical operations solutions available in a flexible functional service provider (FSP) model to meet your unique needs.
Fill your gaps through our breadth and depth of therapeutic and functional expertise
Our experienced clinical operations professionals are uniquely positioned to deliver the right experience and knowledge to fill your clinical operations gaps across a full range of services.
Clinical monitoring
Follow clinical monitoring plans using a customized combination of central, remote and on-site tools to ensure patient safety, data quality and protocol compliance.
Site management
Facilitate high-touch communication between your client, project team and sites throughout all phases of a study to assure efficient and reliable site management.
Clinical oversight
Oversee protocol adherence, patient safety, process efficiency and trial delivery and contribute to standardization and consistency across studies, countries and regions.
Clinical support services
Provide trial master file (TMF) system setup and support, site operational support, preparation and coordination of local regulatory submissions, investigational drug supply and protocol support, and oversight of contract negotiation and finalization with sites.
Site engagement
Enhance performance through development and management of strong site relationships, non-protocol related oversight of quality across studies and clinical team advisement on study-specific site selection, management strategies and best practices.