CRO - Functional Capabilities

• Manages trial deliverables to time, quality, and budget
• Responsible for overall trial delivery
• Responsible for oversight of site management: feasibility, contracting, enrollment
• Leads Investigator Meetings, Kick-Off Meetings, and Core Team Meetings
• Responsible for vendor management including labs, drug supply, DSMB, IxRS
• Establishes and implements risk management and mitigation plans
• Utilizes CTMS to effectively manage all trial components

Sarah Cannon Development Innovations has a fully-dedicated site activation team who effectively identify sites that will enroll to each trial, and efficiently work with the sites and Budget/Contracting to get the sites activated and ready for First Patient In very quickly. Additionally, Sarah Cannon Development Innovations unique model with the Sarah Cannon Research Institute SMO allows for an expedited site start-up for our strategic sites.

Services include:

• Identify potential sites using internal Site Database and external sources
• Create and distribute site feasibility questionnaires
• Work with the project manager/sponsor to finalize site list
• Initiate and execute start-up activities for each site
• Submit central IRB/ethics submission to sites
• Facilitate budget/contract negotiation/execution with sites
• Facilitate regulatory review of clinical trial documentation for each site
• Track and collect site regulatory documents from each site
• Participate in site start-up management
• Participate in site training

Sarah Cannon Development Innovations has a team of in-house clinical research associates/monitors who are highly experienced in oncology and early phase clinical research. In addition to traditional monitoring activities, we are also able to utilize remote monitoring and risk-based monitoring approaches based upon trial design.

Services include:

• Serve as primary point of contact for clinical sites and investigators
• Review clinical data, source documentation, CRF, and investigative site regulatory files
• Perform and document PSVs, SIVs, interim monitoring, and COVs
• Lead protocol specific training to sites at SIVs
• Ensure ICH/GCP compliance
• Monitor drug accountability
• Ensure data integrity

Sarah Cannon Development Innovations offers a full complement of pharmacovigilance, medical monitoring, regulatory, and medical writing services through its Medical Affairs division. The Sarah Cannon Development Innovations Medical Affairs team members have a blend of biopharmaceutical, CRO, and site-level experience; and the unique ability to integrate into the individual culture of each client.

Safety

Services include:

• Safety Operations
• 21 CFR 11 compliant validated safety database
• SAE reporting and triage
• MedDRA coding and SAE reconciliation
• Clinical narrative writing and safety summary reports
• Expedited safety reporting to US and EU regulatory agencies
• Periodic reporting: US and EU (IND-AR, DSUR)
• Safety Plan Development: safety risk management plans, safety handling plans, medical monitoring plans
• Perform Analysis of Similar Events (AOSE)
• Facilitate periodic safety monitoring meetings and updates to the Sponsor
• E2B gateway set up for European regulatory authorities for SAE Reporting
• Cardiovascular Evaluations and Adjudication (CEVA) set up and maintenance

Medical Monitoring

Services include:

• Global medical monitoring services with full-service or hybrid model options
• Protocol development support
• Dose escalation and DLT/MTD activities
• Drug Safety Monitoring Board participation
• Medical consulting services
• Safety reporting oversight and assessment

Regulatory Strategy

Services include:

• Development of regulatory strategy
• Global regulatory intelligence
• Gap analyses and assessment of scientific and technical data for various submissions/authorizations
• Agency liaison and meeting coordination and representation
• Sponsor support for interactions with regulatory authorities
• Preparation and coordination of Clinical Trial Applications
• Consultation and support for Orphan Drug, Fast Track, and Pediatric applications
• Maintenance of applications
• ClinicalTrials.gov registration, maintenance, and results posting

Regulatory Operations

Services include:

• Develop and review regulatory documents for submission
• Review submissions for verification of compliance with applicable guidelines
• Prepare and submit annual reports and maintain regulatory submissions
• Prepare briefing documents
• Interact with regulatory authorities on behalf of clients

Medical Writing

Services include:

• Protocol development and review
• Informed consent development and review (US and ex-US)
• IB writing support
• Manuscript development
• Clinical Study Report development
• IND/DE Support
• Abstract Support
• Conference Poster and Presentation Support

Sarah Cannon Development Innovations offers a full complement of data management and statistical services through its Data Science division. The Sarah Cannon Development Innovations Data Science team members possess a distinctive blend of biopharmaceutical and CRO experience, and have the unique ability to integrate into the individual culture of each client. We maintain a comprehensive library of EDC/CRF, programming and output standards that facilitate accurate, efficient and timely collection, processing and reporting of oncology trial data.

Biostatistics

Services Include:

• Clinical trial design and protocol development
• Sample size and power analysis
• Development of statistical analysis plans
• Statistical analysis and output generation
• Creation of custom reports and graphics
• Data integration services
• CDISC-compliant SDTM and ADaM dataset development
• Statistical interpretation of trial results
• Statistical consulting in regulatory activities

Data Management

Services include:

• Use of CDASH-compliant EDC/eCRF standards
• Development and implementation of data management and data transfer plans
• In-house eCRF and clinical database development
• Development of comprehensive CRF completion and data entry guidelines
• Site and CRA training for data entry related matters
• Creation of standard and custom reports for database management
• Rolling clinical data reviews to facilitate database lock
• Real-time data cleaning and validation for timely decision making
• Management and integration of vendor-derived data
• Comprehensive coding services (MedDRA, WHO Drug, sponsor specific dictionaries)

Traditional CRO Partnership

• Full CRO support combined with access to experienced physician leadership team and long-standing site relationships. Adoption of standards allows greatest value

Full Clinical Development Outsourcing

• Experienced physician leadership and director-level leaders work collaboratively within the Innovations team to develop and implement the clinical strategy for the molecule