Study Rescue/Cleanup Services
DSP offers specialized study rescue/cleanup services to get your trial back on track if it has fallen behind schedule, you are experiencing problems with data quality, or costs are out of control. We can take over management of your trial at any point and rapidly clean up the problems that your trial is facing.
Regulatory Strategy and Support
Development of regulatory submissions strategy and implementation of regulatory-compliant submissions processes.
Paper and eCTD-based regulatory compliant document authoring, management, preparation, and publishing services.
Investigator Site Audits
- verification of source documents and data collected.
- informed consent processes and documentation.
- adherence to company and institutional SOPs.
- compliance with FDA regulations, GCP Guidelines and protection of human research subjects.
- review of site procedures.
- IRB Audits.
- quality systems audits.
- investigator selection and qualifications.
- study conduct.
We also perform CRA audits, CRO audits, and on-site audits of your vendors and suppliers.