Our project managers have a broad understanding of clinical trials and the strategies to deliver them efficiently. They coordinate the interactions of multidisciplinary teams and are always focused on delivering your project on time and on budget. Throughout the clinical trial, you will have a single project manager who will be your primary point of contact. Regulatory approvals are time-sensitive and can be a major cause of delays. Deloitte has a dedicated regulatory team to help you develop an effective regulatory strategy for your project.

Our project management & regulatory services include:

• Execute the Clinical investigation/Bench Test on time and on budget
• Mitigate project risks
• Support negotiating study agreements
• Support authority and ethics committee meetings
• Prepare relevant documentation
• Obtain authority and ethics approvals
• Run a Clinical Event Committee (CEC)/Bench Tests
• Organize and execute investigator and Data Monitoring Committee (DMC) meetings
• Write newsletters and journal articles to accelerate patient recruitment

Our highly skilled, MedTech-focused team works with KOLs, investigators, and study team members to ensure that the clinical investigation is conducted in accordance with the clinical investigation plan and in compliance with local regulatory requirements, ISO 14155 and the Declaration of Helsinki. Through our many years of experience, we understand the importance of a good relationship with your customers to ensure the delivery of high-quality data in the shortest possible time throughout the course of the study.

Our services include:

• Partner with the study team
• Provide trainings and support during the course of the clinical trial/bench test
• Design and maintain Investigator Site Files (ISF)
• Prepare study sites for audits
• Expediting study completion through "on-the-fly" study nurses
• Advise on risk-based monitoring

We conduct onsite and remote:

• Site Selection Visits (SSV)
• Site Initiation Visits (SIV)
• Regulatory Monitoring Visits (RMV)
• Source Data Verification (SDV)
• Close-out visits (COV)

From study start to finish, we provide comprehensive eClinical solutions for setting up and conducting your clinical investigation. We offer customized design and the programming of intuitive eCRFs to ensure efficient data capture and analysis.

With our eClinical solutions we provide:

• EDC, ePRO, eCOA, eTMF, eISF, telemedicine
• Design Electronic Case Report Forms (eCRFs)
• Programming of eCRFsData management documentation
• Error detection and data clean-up
• Data transfer to Imaging CoreLab
• Organize and lead Data Monitoring Committees (DMCs)
• Amendments in adaptive study designs
  

Clinical Research by Deloitte develops an understanding of your short- and long-term product and business goals to provide tailored biostatistical support during the strategic planning phase and study execution. Using publicly available data and/or internal data from previous clinical trials, we help you to define statistically justified patient numbers.

Our services include, but are not limited to:

• Strategic planning of a lean, robust study/bench test design
• Analysis of clinical trials and publications
• Support competent authority meetings
• Design of the Statistical Analysis Plan (SAP) that can be adapted to changes in study design
• Preparation of tables, figures, and listings
• SAS programming
• Writing the Statistical Analysis Report (SAR)
• Linking of data from different (also previous) studies/bench tests