BA/BE Studies Monitoring , Auditing & Project Management
BA/BE Studies Monitoring
Our skilled and well-trained clinical research associates (CRAs) ensure the highest quality review of data and effective interaction with CRO (BA/BE). Our clinical research associates conduct on-site monitoring visits throughout the study to:
- Oversee data collection and data integrity
- Ethical conduct of study
- Ensure Safety of trial participants
- Review source documentation and case report forms
- Ensure regulatory and Protocol compliance
- Resolve data queries
CRO management
Facilitate high-touch communication between client, project team and CRO (BA/BE) throughout all phases of a study to assure efficient and reliable site management.
Clinical oversight
Oversee protocol adherence, subject safety, process efficiency and trial delivery and contribute to standardization and consistency across studies, 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 CRO (BA/BE).
CRO engagement
Enhance performance through development and management of strong CRO (BA/BE) relationships, non-protocol related oversight of quality across studies and clinical team advisement on study-specific CRO (BA/BE) selection, management strategies and best practices.
GCP Clinical Auditing
A company that conducts clinical trials on investigational medicinal products (IMP) that involve the participation of human subjects, must prove that the design, study conduct, performance, monitoring, auditing, analysis and reporting, all meet the international ethical and scientific standards of Good Clinical Practice (GCP).
Through our GCP auditing capabilities, we can provide assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected. Laboratories that perform analysis of clinical trial samples must also conduct laboratory services to GCP standards.
Bio Soft Research provides many global organizations, both product development companies and contract research Organizations (CROs), with GCP auditing expertise. These services help to ensure that adoption of the principles of GCP meet international standards where trials are conducted to test on Investigational product. Supporting GCP compliant human clinical trials, Our Total Quality Assurance expertise enables you to identify and mitigate the risk in your operations, supply chains and business processes.
Bio Soft Research GCP Quality Assurance services:
- Document review and audit for example SOPs, Clinical GCP Protocols and Reports
- Audits of submission for ethical approval for GCP clinical trials
- Audit of clinical phase and Bio-analytical phase
- CRO (BA/BE) qualification audit
- Final Clinical Study Report (CSR) audit
- Sub-contractor audits (laboratories, archives, e-EDC, and others)