Our faculty are known throughout the world for their expertise in clinical study design and development. We can work with study sponsors and research investigators throughout the course of a trial, leading protocol design and development, serving as principal investigators as applicable, providing guidance through the FDA application process and more.

• Protocol Design and Development
• Design de novo study protocols, incorporating the latest digital technologies and advancements in statistical analysis and clinical study execution
• Review existing study protocols and provide feedback to sponsors including FDA guidance
• Principal Investigator Services
• Provide advice and guidance regarding clinical study protocol, design and strategy
• Assure successful trial execution, data analysis and dissemination of trial results
• Provide advice on post-trial strategies including publication and positioning at major conferences
• Review of trial materials and communication with trial participants
• Participation in trial planning meetings
• FDA Application Preparation
• Provide regulatory advice and support regarding IDE or PMA application preparation

Our center offers a full array of clinical study management services, including both clinical trials and registry studies. We quickly identify high performing sites through our network of hundreds of research centers. We work with sites to manage study enrollment, maintain documentation, and assure we meet all reporting and regulatory requirements in a timely and accurate manner. We have a trusted team of international vendors that we contract with for remote monitoring services and our skilled project managers and clinical research associates work alongside your team to assure seamless implementation.

• Site Identification and Qualification
• Identify qualified sites globally to participate in clinical studies
• Collect, review and store requisite site documents to assure investigator and site qualifications
• Assist with IRB and Ethics Committee application preparation
• Assist in completing country specific regulatory filings so that sites can participate in clinical studies
• Maintain site metrics to assure high performing sites in future clinical studies
• Site Management and Monitoring
• Maintain comprehensive site auditing by using real-time data to examine trends among risky sites
• Engage with experienced partner organizations to conduct both traditional on-site and remote monitoring, as well as risk-based monitoring
• Develop monitoring plans in collaboration with study sponsors, and monitoring service providers
• Conduct site initiation visits, train site investigators and staff, and identify/address potential roadblocks to enrollment and subject retention
• Over the course of the study, conduct on-site and remote monitoring visits to ensure data accuracy and protocol adherence
• Clinical Study Management
• Develop and maintain project plans and timelines
• Establish and maintain consistent communication between sponsor, vendors, study sites and study staff
• Develop standard operating procedures ensuring ongoing training for project staff
• Produce regular metric and KPI reports for study sponsor and sites

Our biostatistics and data management team has deep experience in developing statistical analysis plans, building and maintaining electronic data capture systems, and managing complex data sets. We meticulously manage our data-driven projects, assuring protocol compliance, and develop detailed study reports and tables, which aid in both our study management capabilities and our ability to produce high caliber publications.   

• Statistical Analysis Plan Development
• Develop SAPs for clinical studies, assuring appropriate sample sizes and endpoints
• Extract and run data tables and listings
• Electronic Data Capture (EDC) System Development and Management
• Harvest data from Electronic Medical Record/Source to support quality research initiatives
• Liaise with in-house EDC developers to customize user application and analysis needs
• Provide data capture solutions to support real time trial monitoring, data collection and longitudinal follow up
• Data Collection and Management
• Track, review, and query data that comes in-house to guarantee protocols are properly followed
• Assure protocol compliance and check for data consistency and accuracy from data submission sites      
• Identify and communicate with delinquent sites regarding data completion and/or submission
• Develop study specific reports and tables to assist with study monitoring and data cleaning
• Coordinate data management projects, including pooled and/or shared datasets, assuring clean datasets are available for publication purposes 

Safety and quality services are the backbone of our center. We provide safety reporting and medical monitoring support across studies, working with sponsors and the monitoring team to assure investigators are responsive and compliant throughout the duration of the study. We also organize, train, and manage clinical event committees and data safety monitoring boards, providing the highest level of quality control and project management services.       

Our services include:

• Safety Reporting and Medical Monitoring
  • Develop process flow procedures for adverse event (AE/SAE) reporting applicable to the trial protocols
  • Review reported SAEs that are made available by sponsor per predetermined processes and intervals
  • Conduct trigger reviews to identify field results that could meet criteria for SAEs but were not recorded in trial database
  • Interface with the electronic data capture (EDC) for timely notification of SAE or endpoints entered by sites
  • Distribute safety letters to investigator sites, ethics committees and institutional review boards
  • Prepare safety summary reports to sponsor and country regulatory bodies annually and at intervals as necessary
  • Work with the sponsor and monitoring team to ensure investigators are compliant through training and consultation

We organize, train, and manage clinical event committees, providing the highest level of quality control and project management services.

• Clinical Event Adjudication and Committee Management
  • Direct, manage, and oversee timely event adjudication meetings to meet project deadlines and milestones
  • Develop trial specific CEC charter and work instructions based on the trial protocol and our standard operating procedures (SOPs)
  • Create and maintain scheduled communication with sponsor and CRO to identify endpoint events/triggers, query management and resolution
  • Provide CEC member selection without bias or commercial interest in protocol to establish a multidisciplinary team of physicians with board certification relevant to the protocol
  • Conduct training to CEC members on protocol definition and committee processes
  • Coordinate event identification notification and source document retrieval
  • Provide source document review for blinding; redacting and translating as applicable
  • Provide event narratives
  • Provide CFR-21 compliant EDC system for adjudication results
  • Distribute timely meeting minutes for sponsor, DSMB and regulatory review
  • Storage of all source documents and meeting minutes on site for five (5) years

We organize, train, and manage data safety monitoring boards, providing the highest level of quality control and project management services.

• Data Safety Monitoring Boards (DSMB)
  • Develop trial-specific DSMB standard operating procedures
  • Create a DSMB charter appropriate for the protocol
  • Develop DSMB membership in collaboration with the sponsor, assisting with member identification and selection
  • Conduct DSMB member training through protocol, clinical endpoints, and DSMB procedures. Provide continuous assessment and feedback
  • Plan and organize DSMB meetings, developing relevant, controlled materials and liaising with the chair for timely and smooth event reporting
  • Distribute monthly progress reports to DSMB members as applicable for enrollment, events, etc.
  • Assist with selecting independent biostatisticians for analysis of blinded reports
  • Draft and distribute open meeting minutes
  • Document quality control and adherence to procedures

We share our insights and study results through educational venues. Our faculty not only presents regularly at major cardiovascular conferences around the world, but our center also develops novel educational programs to help to shape the landscape of global cardiovascular care. Examples include online and live programs for practicing physicians and allied health professionals, as well as think tank programs to bring key stakeholders together for shared learning and innovative decision-making.

• Educational Program Development
• Design needs-based educational curricula, including KOL faculty members
• Incorporate multiple formats, including live, online and other enduring materials
• Manage program and/or event logistics including onsite support services
• Design and manage marketing and communications campaigns in support of educational activities
• Preceptorships and Think Tanks
• Design custom experiences for sponsor partners, including didactic and case-based learning, live case demonstrations and facilities tours
• Organize topical forums, including top thought leaders and subject matter experts
• Liaise with leading academic institutions and professional organizations