FORTREA CONFIDENTIAL – PERSONAL INFORMATION

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QMS-AD-043 version 01

Gatto, Diane Marie

Clinical Team Lead, Canada

Employment History

Fortrea (Formerly Labcorp), Toronto, Ontario, Canada – May 2023 - Present Clinical Team Lead – May 2023 - Present

Labcorp, Toronto, Ontario, Canada – Apr 2022 –May 2023 Clinical Team Lead – Apr 2022 – May 2023

• Take accountability for proactively driving clinical project performance toward contracted deliverables while meeting customer needs and maintaining operational excellence

• Drive communication and collaboration with the client and project team across a matrixed, multi- cultural, environment. Lead the development of the clinical project strategy and ensures prioritization with the clinical project team and key stakeholders in the creation of clear, data driven strategies and proactive management of project scope, timelines, quality and budget. In collaboration with relevant departments, prepare and deliver presentations for new business as required

• Manage the operational aspects of projects to support subject recruitment and retention, clinical vendor delivery and oversee the monitoring visit strategy

• Identify clinical project, financial and quality risks leveraging end to end risk management practices and quality by design principles. Appropriately utilize data sources, dashboards and risk management strategies to drive innovation and proactive problem solving with the project and client teams. Adhere to project governance and issue escalation pathways, ensuring that clinical project plans are in place to address identified risk while adhering to professional standards, SOPs, client and regulatory requirements

• Partner with project team members and key stakeholders to oversee and manage clinical project budgets, resources and scope. Ensure adherence to established budget and financial milestones. Accountable for accurately forecasting clinical project revenue and managing project costs in adherence to the budget. Leading the timely management of changes to scope and the change order process. Ensures project team awareness and tracking of KPIs for any client specific metrics

• Provide inspiring leadership and play a key role in the creation of high performing clinical project teams. Facilitating communication and teamwork while driving delivery, ensuring that clinical team members understand contracted scope, timelines and budget. Ensures that clinical resource projections are accurate and visible to resourcing teams, proactively escalating resource constraints and challenges. Develops and mentors team members in multiple areas of expertise and provide feedback as needed to respective line managers Name: GATTO, DIANE MARIE

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LabCorp, Stoney Creek, Ontario, Canada – May 2017 - Apr 2022 Sr. Clinical Research Associate II – May 2017 - Apr 2022

• Prepared all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits. Liaise with vendors and other duties, as assigned.

• Prepared all aspects of site management as prescribed in the project plans.

• Conducted General On-Site Monitoring Responsibilities. Ensure audit readiness at the site level.

• Ensured the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.

• Ensured the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.

• Ensured the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data.

• Ensured the resources of the Sponsor and organization are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to travel policy.

• Reviewed progress of projects and initiate appropriate actions to achieve target objectives. Manage small projects under direction of a Project Manager/Director as assigned.

• Negotiated study budgets with potential investigators and assist the legal department with statements of agreements as assigned.

• Served as lead monitor for a protocol or project and may assist in establishing monitoring plans and trip report review as assigned.

LabCorp, Stoney Creek, Ontario, Canada – Jul 2015 - May 2017 Sr. Clinical Research Associate I – Jul 2015 - May 2017

• Ensured all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties as assigned.

• Ensured all aspects of site management as prescribed in the project plan.

• Ensured General On-Site Monitoring Responsibilities: Ensured the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.

• Ensured the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.

• Ensured the integrity of the data submitted on Case Report Forms or other data collection tools by careful source document review.

• Ensured Monitored data for missing or implausible data. Name: GATTO, DIANE MARIE

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• Ensured the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy.

• Prepare accurate and timely trip reports.

• Ensured audit readiness at the sire level.

Idoman Canada, Toronto, Ontario, Canada – May 2011 - Oct 2014 Project Manager – May 2011 - Oct 2014

• Prepared pre-study visit, initiation and interim monitoring and close-out visit material for clinical sites (e.g., CRF completion guidelines, monitoring guidelines, investigator brochure, and all study- related templates.

• Participated in the development and design of the clinical protocol.

• Planned in completing the regulatory package submitted to the FDA, in writing the study protocol, in choosing the potential Investigators, and in the development of study-related key documents; planned managed and supervised the conduct of the clinical research trial, including supervision of various contract research organizations (CROs) and vendors (e.g., central laboratories).

• Supervised the Clinical Trial Assistant as well as study monitors (Clinical Research Associates) and reviewed their monitoring visit reports; planned, managed and supervised the conduct of the clinical research trial, including supervision of various contract research organizations (CROs) and vendors (e.g., central laboratories).

• Set up and developed the Trial Master File, collected and managed all regulatory site documents; communicated directly with study coordinators, Investigators and vendors on a regular basis to maintain compliance with study protocol and address any concerns and problems during the course of the trial.

• Assisted in organizing Investigators meetings and participated as a presenter; participated in the identification of potential Investigators; created and maintained a tracking system of the Clinical Trial Study Payment to be made to study sites and vendors; negotiated clinical trial budgets and contractual agreements with Investigators.

• Trained study team on aspects of protocol as well as study-related clinical, regulatory and GCP/ICH Guideline issues; accomplished by detailed review of subject records, essential documents, Investigational product disposition and accountability, site personnel and procedures.

• Worked with key functional departments to coordinate the project-related activities; performed quality control co-monitoring visits, as needed; participated in activities related to data management and analysis (e.g., review of the statistical analysis plan, establishment and revision of SOPs within the company).

Name: GATTO, DIANE MARIE

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i3 Research Inc., Burlington, Ontario, Canada – Oct 2006 - May 2011 Senior CRA – October 2006 - May 2011

• Performed routine site visits including pre-study, initiation, interim, and close out visits; performed responsibilities with minimal support from management; visits included monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines and other applicable regulatory requirements.

• Assured good site performance, accomplished by detailed review of subject records, essential documents, investigational product disposition and accountability, site personnel and procedures.

• Managed assigned sites by regular contact to ensure site compliance, adequate enrollment, and understanding of study requirements.

• Reported to company project team, client, and site personnel any findings noted at monitoring visits, accomplished by completing monitoring reports and follow-up letters within the project- specific timelines; reported significant issues noted to appropriate personnel immediately.

• Maintained eClinical or alternative project tracking system of subject and site information.

• Participated in company required training programs.

• Performed necessary administrative functions (e.g., tracking of expense reports, time and attendance).

• Maintained home office (e.g., procured office supplies, submitted documents). Independent Consultant, Hamilton, Ontario, Canada – Oct 2004 - Oct 2006 Senior CRA – Oct 2004 - Oct 2006

• Worked in conjunction with numerous companies, performed routine site visits, including pre-study, initiation, interim, and close-out visits, performed responsibilities with minimal support from management, visits included monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines and other applicable regulatory requirements, and assured good site performance accomplished by detailed review of subject records, essential documents. Investigational product disposition and accountability, site personnel and procedures

• Reported to company project team, client and site personnel any findings noted at monitoring visits, accomplished by completing monitoring reports, and follow-up letter within the project specific timelines, reported significant issues note to appropriate personnel immediately

• Maintained eClinical or alternative project tracking system of subject and site information

• Participated in company-required training programs

• Maintained home office (e.g., procured office supplies, submitted documents)

• Maintained a project tracking system of subject and site information Name: GATTO, DIANE MARIE

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Boehringer-Ingelheim, Burlington, Ontario, Canada – Jun 2002 - Oct 2004 Data Manager – Jun 2002 - Oct 2004

• Provided study-specific support to the Data Management team on a large Phase III trial for all data management activities for 12 sites

• Performed discrepancy management to assigned sites using ORACLE Clinical

• Interacted with Investigator sites and monitors to resolve data discrepancies and with clinical colleagues to resolve data and monitoring issues

• Tracked and monitored the receipt of CRF pages from the Investigational sites

• Monthly Data Quality Review Meeting (DQRM) meetings Hamilton Regional Cancer Centre, Hamilton, Ontario, Canada – May 1994 – May 2002 Clinical Trials Department – Clinical Research Associate – 1998 - 2002

• Randomized patients and monitored clinical trials

• Obtained, reviewed, and verified informed consents for eligible patients in collaboration with physicians and against SOPs, IRB/REB requirements

• Provided input to the maintenance and operation of data management standards

• Reviewed protocol to ensure consistency with data management standards

• Participated in trail preparation, Investigator meetings and Clinical Research Associate training

• Assisted in design and development of Case Report Forms to ensure transparency with data entry and data management

• Designed the database and prepared database validation plan and report, gained experience with Remote Data Entry and Data Quality Plan, Data Edit Checks, and monitoring programs

• Established and maintained Data Quality Plan, Data Edit Checks., and monitoring programs

• Reported serious adverse events to relevant team members and the REB

• Organized, prepared, and processed charts for audits, processes letters to IRB/REB for approvals and renewals, regulatory content and upkeep

Health Record Technician –1994- 1998

• Complied and utilized health statistics, using Meditech statistical program

• Gained experience using an electronic medical/health information system, including ADT, Dictation/Transcription, and Coding and Abstracting

• Released Information in accordance with professional ethics, institutional policy and Hospitals Act

• Collected information regarding the status of oncology patients

• Coded neoplasms by topography, histology and behavior

• Gained knowledge of International Classification of Diseases (ICD-9-CM/ICD & ICD -10 and CPT/HCPCS) coding systems

Name: GATTO, DIANE MARIE

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King Edward VII Memorial Hospital, Bermuda – August 1987 – November 1992 Supervisor of Clinical Records – August 1987 – November 1992

• Managed all health records, consolidated statistical information and processed in relation to the delivery of clinical services and the management and development of the Health Information Management System

• Planned and developed standards

• Developed and reviewed policies and procedures to enhance service delivery

• Maintained the Patient Record Privacy and adhered to the privacy of and access to patient health information

• Exercised initiative and independent judgment in determining work priorities and work methods

• Provided leadership to create an environment conducive to effective work St Joseph Hospital, Hamilton, Ontario, Canada – July 1980 – July 1987 Health Record Technician – Jun 1980 – July 1987

• Gained experience using electronic medical/health information systems

• Maintained historical reference by abstracting and coding clinical data, such as diseases, operations, procedures, and therapies, using standard classification systems, filed documents

• Gained knowledge of International Classification of Diseases (ICD-9-CM/ICH – ICD-10 and CPT/HCPCS coding systems

• Complied and utilized health statistics, using Meditech statistical programs, maintained patient confidence and protected hospital operation by keeping information confidential followed release of information protocols

• Maintained medical records operations by following policies and procedures, reported needed changes, initiated medical records by search master patient index, identified existing patient records or assigned a new number when needed, interacted with registration areas and physician offices for information verification, processed and created the record folder

• Ensured medical record availability by routing records to admissions and emergency departments, physician, and other authorized hospital staff, maintained chart location system

• Completed medical records by reviewing information, notified health care providers of record deficiencies, tracked outstanding records, notified medical director of physicians in jeopardy of losing admitting privileges

Name: GATTO, DIANE MARIE

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Therapeutic Experience

CardioMetabolic

• Cardiovascular Disease (Phase III)

Oncology

• Solid Tumor – Breast, Colorectal, Lung Cancer (Small and Non-Small Cell Lung Cancer) Prostate, Pancreas, Head & Neck, Hepatocellular/Liver, Melanoma, Ovarian, Renal Brain Tumors (Phases I, II & III)

• Hematologic Malignancies –Leukemia, Hodgkin’s Lymphoma, Myelodysplasia, Myeloma Cancer supportive care – Anemia due to chemo, Mucositis due to chemo and/or Radiation therapy, nausea/vomiting due to chemo, Chemo/Radio protectant, Cancer pain (Phases I, II & III)

Special Patient Population

• Pediatrics – Duchene Muscular Dystrophy (phase I)

• Devices - Diagnostic procedure/ device evaluation (phase I) Other

• Ophthalmology (Phase III)

• Infectious Diseases Chronic Hepatitis (Phase I & Phase II), Coronavirus Disease (COVID-19)

(Phase IA and II), Sepsis Shock (ID) (Phase III)

Neuroscience

• Neurology - Other CNS (Phase II)

Systems Experience

Not Applicable

Language Capabilities

• English - ILR 5 (Native or Bilingual)

• Italian - ILR 2 (Limited Working Prof)

• French Canadian - ILR 2 (Limited Working Prof)

Education

• Diploma, Niagara College of Applied Arts and Technology, Welland, Ontario, Canada

• Diploma, McMaster University, Hamilton, Ontario, Canada

• Diploma, Ontario Health Records Association, Toronto, Ontario, Canada

• Diploma, Hamilton Health Sciences, Hamilton, Ontario, Canada

• Certified MedDRA Coder

• Certified Clinical Research Coordinator (ACRP)

• Certified MedDRA Coder

Training

Not Applicable

Name: GATTO, DIANE MARIE

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Memberships/Awards

• Society of Clinical Research Associates Board Member

• Society of Clinical Research Associates Member

• Ontario Health Records Association Regional #5 Chairperson

• Hamilton Wentworth District Health Council Board Member

• Society of Clinical Research Associates Exam Facilitator

• Society of Clinical Research Associates Annual Conference Facilitator

• Hamilton Regional Cancer Centre Editor

• Ontario Cancer Center Technical Coding Committee Coding Committee

• Health Records Association Newsletter - News & Views Editor - News & Views

• Bermuda Hospitals Board Editor-Pulse

Other

Not Applicable

Employee Signature: Date: Fortrea will become the new brand identity for Labcorp's Clinical Development business in connection with the spin-off from Labcorp, which is expected in mid-2023. Fortrea's spin-off from Labcorp is subject to the satisfaction of certain customary conditions, including, among others, the receipt of final approval by Labcorp’s Board of Directors, the receipt of appropriate assurances regarding the tax-free nature of the separation and effectiveness of any required filings with the Securities and Exchange Commission. There can be no assurances regarding the ultimate timing of the transaction or that the spin-off will be completed. Until the spin-off is complete, Fortrea's products, services and offerings are still owned and operated by Labcorp.

Unpublished Work Copyright 2023, Labcorp Holdings Inc. Name: GATTO, DIANE MARIE

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Appendix 1

Publications

• Diane Gatto (CY11). Multicenter Outpatient Thermal Balloon Endometrial Ablation (Thermablate) with or without Concomitant Hysteroscopy Fallopian Tube Microinserts (Essure)"

• Diane Gatto (CY03). Understanding What Clinical Trials Are All About from a Patient Perspective Abstracts

Not Applicable

Manuscripts

Not Applicable

Contact this candidate