Anthony Bonanno Email and Phone Number

- Adheres to scope and routinely reviews Clinical Trial Management System (CTMS), Case Report Form (CRF), drug management, safety, Trial Master File (TMF), IVRS/IWRS enrollment, Data Visualization dashboards (where available) to oversee site and study team conduct, to ensure timely entry of all operational aspects according to plan, and to oversee site and study team conduct and identify any risks to delivery or quality- Ensures quality of the clinical monitoring and site management deliverables- Participates in the development of the study risk assessment plan. - Reviews the content and quality of site monitoring documentation to ensure they represent site management activities and conduct. - Interacts with the client and other functional departments related to clinical monitoring and site management activities and deliverables.- Collaborates with other functions to ensure site compliance and delivery according to protocol, ICH/GCP and or Good Pharmacoepidemiology Practices (GPP) and country regulations. - Ensures alignment of clinical activities to budget, including identification of out of scope activities.- As required, provides development and delivery of initial and ongoing training to the study team and timelines for the study. Plans and leads regular clinical study team calls to provide status updates, ongoing training and accountability to deliverables.- Adheres to scope to ensure assigned clinical staff routinely assess site processes, perform review of all Source Documents and medical records, and perform Source Document Review (SDR) and/or Source Document Verification (SDV) per the CMP/SMP and reviews identified and newly emerging risks. - May evaluate staff’s competency to perform visits/site contact independently via sign-off visits and Monitoring Evaluation Visits (MEVs) according to company SOPs.- May participate in business development proposal and defense meetings - May be involved in Business Unit-level initiatives

-Completes project activities associated with monitoring functions of Phase I-IV clinical research studies while continuing to develop knowledge of the drug development process, Good Clinical Practices, and relevant regulations. -Provides clinical and technical support for CRA's and administrative staff. -Performs management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures (PSOPs).-May assume the role of a Lead CRA on projects by providing direction and guidance to project team, coordinating all monitoring activities, and communicating the status of these activities to the study Project Leader. -Mentored new team members and trained team members on monitoring techniques and study specific training.

Collaborated in the development of Standard Operating Procedures (SOP’s) for the Clinical Research Department-Collaborated with Regulatory Department in the review of Clinical Protocols, Informed Consent Forms, and Investigator Brochure (IB) for Phase 2 trials before the Clinical Documents were submitted to the FDA-Involved in the development of clinical forms, study procedures and filing systems-Involved in the development of Clinical Protocols, Amendments, Clinical Reports and other study documents (e.g. study aids/ tools)-Responsible for the monitoring oversight and close out of a Phase I stroke trial-Responsible for the monitoring oversight of a Phase II Myocardial Infarction and Cardiopulmonary Bypass trials-Contributed with the development and assembly of Pharmacokinetic (PK), Pharmacodynamic (PD) and Cardiac Biomarker kits for a Phase II Myocardial Infarction Trial-Contributed in the tracking and distribution of study drug, laboratory kits, and clinical study supplies-Collaborated with the Clinical Trial Manager regarding site payments and oversight of Contract Research Organization (CRO) for a Phase II Myocardial Infarction Trial-Responsible for the tracking, entering and reviewing of data in clinical trials-Involved in the development of Case Report Forms (CRF’s), CRF tracking sheets and data management forms

Performed pre-study visits, initiation visits; routine monitoring visits and closeout visits.-Completed monitoring reports. Responsible for the completeness of study files.-Responsible for generation of monitoring plan and monitoring guidelines for an open label study.-Communicated frequently with clinical investigators and site personnel to coordinate supplies for a timely and well-controlled implementation of clinical studies-Ensured delivery of completed CRF’s and communicate with investigators to ensure proper clarification of questions arising from internal review of the data-Involved in the preparation of investigator contract, study tracking and payment coordination-Involved in the review of regulatory documents as needed-Processed, tracked and filed incoming clinical data-Ensured proper submission and processing of clinical data in a consistent manner to appropriate medical reviewers for a diabetic study-Organized and maintained tracking spreadsheets such as site enrollment, eligibility and normal control spreadsheets.-Processed and tracked exported clinical data that was received off site and in house and ensured that the data was given to the appropriate individuals in house.-Primary contact for Regional CRA including review of monitoring reports and management of monitor related issues.-Assured compliance of clinical studies with good clinical practices (GCP), federal regulatory requirements and standard operation procedures (SOP’s)

-Interacted with client and project team as necessary to establish data review guidelines and data flow procedures-Documented, resolved and integrated data queries. Completed all relevant audit trial materials-Reviewed data discrepancy listings, with associated data query documentation, resolution, and integration-Tracked and reported data management status-Performed database audit (s) with project database manager-Communicated/coordinated with project manager, statistician, clinical research associate, database manager, and data support specialists to ensure clean database-Interacted with clients as necessary

-Reviewed incoming clinical records, trouble shoot data and the clinical case being aware of the protocol-Maintained clinical database with data obtained from sites-Reviewed EEG recordings for product performance during various trials-Processed data recorded at clinical sites for in-house review-Corresponded with multiple sites on a daily bases regarding clinical data and clinical requests-Responsible for updating clinical site addresses and contacts-Maintained clinical files and IRB, protocol and e-mail correspondence-Interacted with various departments within the company to facilitate clinical trials-Ensured the flow of clinical data; review clinical raw data (medical cases, CRF’s) as it arrived at Aspect-Generated Excel charts, plots and worksheets for incoming clinical data-Assisted in generating and reviewing Case Report Forms (CRF) from clinical studies.-Updated and revised clinical bibliography containing studies related to Aspects BIS technology-Prepared information packets for clinical sites and helped marketing department with mailings and information packets about Aspect’s EEG monitor with BIS technology