DSP

Services

Additional Services

DSP partners when necessary to augment our study services. All partners are leaders in their respective fields.

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.

Biostatistics

DSP provides comprehensive biostatistical services to analyze and interpret the results of your study. We can get involved in your study at the earliest stages and advise on all aspects of design, size, and conduct of the study.

Biostatistical services encompass protocol design; development and implementation of statistical methodologies; and the design, analysis and reporting of study results.

Medical writing

Preparation and finalization of clinical study reports and manuscripts.

Regulatory strategy and support

Development of regulatory submissions strategy; development and implementation of regulatory compliant submissions processes.

FDA Submissions

Paper and eCTD-based regulatory compliant document authoring, management, preparation and publishing services.

Investigator Site Audits

We provide comprehensive investigator site audits including:

• verification of source documents and data collected on CRFs
• 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.

• Overview
• Study Management
• TrialTrak
• Site Monitoring
• Investigator Site Management
• Data Management
• Additional Services