- Protocol feasibility analysis
- Project governance plans and project status tracking reports
- Negotiations and finalization of study contracts
- Risk management and mitigation strategy
- Resource allocation and performance management
Project management
Our project managers work in close cooperation with the scientific team to keep client informed on the progress of clinical trial. They efficiently and diligently manage all critical aspects of the study to ensure timely delivery of results
Our experienced project managers make the project run smoothly, on time and on budget with a quality output.
The project managers are responsible for
Main Sponsor Contact:
Our Project managers serve as the main contact for our sponsors/clients. They provide frequent and timely reports.
Training:
Our project managers organize the training of CRAs and site personnel on the protocol, CRF conventions and SOPs.
Manage the Monitoring Effort:
Our Project managers organize and track monitoring coverage. They supervise the CRAs on the project by reviewing their work, maintaining continuous contact, and conducting frequent conference call meetings to assure standards and consistency.
Quality Control:
Our project managers review and approve reports and letters from the CRAs and periodically co-monitor and audit problem sites.
Decision Making:
Our project managers are capable of answering agreed-upon questions from the field regarding patient eligibility and study conduct.
Proactive Approach:
Our project managers are trained to anticipate problems and have solutions to tackle any situation if required.
Management of Budgets and Timelines:
Our project managers are fully responsible for keeping the project within budget and executing within the client's required timelines.
General clinical trial support
- Identification of Principal Investigators and investigational sites
- Lab Identification in accordance with specific region
- Study Supply Management
Scientific clinical trial support
- Medical-scientific assessment of commercial, potential of new products
- Medical-scientific aspects of commercial product development
- Organization of round-tables, seminars, workshops, etc.
- Conferences, oral presentation and papers, etc.
- Training and teaching
The vital responsibility of CRAs is to ensure patient rights, safety and data integrity. This is accomplished through ongoing review of the following:
- Informed consent process
- IRB/IEC approval
- Ensuring proper AE and SAE reporting
- Documentation and follow up
- Adherence to the protocol
- 100% source documentation verification and data query clarification
- Investigational product administration and accountability
- Protocol Compliance
- Site training and support
Site Management
- Site evaluation and selection
- Investigator team training
- Clinical monitoring (source data verification, ICD review, SAE reporting, drug accountability, inventory management)
- Query resolution and database lock
- Site close out and archival of data
- Quality assurance and site audits
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