Clinical and Medical Monitoring Safety

Capabilities and Experience:

We hold up the highest of standards in Clinical Monitoring and Medical Monitoring/Safety in delivering clients’ results:

• Site Management: clinically knowledgeable, with methods that are not only innovative but also in tune with the needs of clients, patients and investigators alike. The results are streamlined, efficient site services that expedite recruitment and study execution
• Regionally based monitors, with 5+ years of experience each, in appropriate countries with experience across all therapeutic areas
• Extensive, on-going training in appropriate countries, in the U.S.: FDA regulations, ICH guidelines and GCP/SOP compliance
• 100 percent Source Document monitoring

Monitoring Meetings Supported:

• Pre-study qualification visits
• Initiation visits
• Interim monitoring visits
• Close out visits
• All activities are performed in accordance with ICH-GCP to ensure all investigational sites are compliant with applicable regulations and protocol requirements
• All meetings include Medical Monitoring by a separate team to ensure regulatory compliance

We provide capabilities covering all aspects of Clinical Monitoring and Medical Monitoring/Safety as well as seasoned people and a technology platform:

We have an unparalleled team in Medical Monitoring/Safety, which is actively involved across therapeutic areas. You can be assured that your study will be conducted according to protocol, that your study subjects will be carefully monitored and that you will have immediate visibility into any potential issues or concerns. Our Medical Monitoring/Safety highlights are outlined below:

• Medical monitoring by a licensed physician is an essential function to ensure the safety of trial subjects and the clinical integrity of trial results
• Our medical monitors possess substantial experience in all phases of clinical trials from protocol development to SAE reporting to regulatory submissions.
• Medical monitors have specific training depending on which disease area they are working

Deliverables:

We offer broad monitoring deliverables, including:

• Investigator qualification/selection and site recruitment
• Investigative site start-up and training
• Facilitation of clinical trial enrollment
• Site regulatory compliance
• CRF completion
• Data collection and query resolution
• Expedited adverse-event reporting

We also offer specific Medical Monitoring deliverables, including:

• Medical review or writing of program/study documents, including Investigators’ Brochures, Clinical Development Plans, Protocols and Final Study Reports
• Review of protocol design and statistical analysis plans
• Review of safety data for trends that are disease-specific
• Independent review of efficacy data
• Evaluation of Serious Adverse Events (SAEs)
• Review coding of adverse events and medications
• Medical oversight of the study, including medical issues arising from study conduct 

Differentiators:

We use our differentiators to guide the design, review and decisions that factor into Product Development planning:

• Document design, review and sign-off from a medical point of view: Investigator Brochure, Protocol, CRF, Informed Consent, Study Manual, Statistical Analyses Plan, Data Validation Plan, Study Reports, SAE Narratives
• Study decisions regarding in/exclusion deviations, dosing questions, concomitant medical requests and emergencies (including 24/7 coverage)
• Listing review of study data and cross referencing critical data fields for consistency: Demographics, Physical Exams, Vitals, Dosing, Labs, EKG, Concomitant Medications, Adverse Events, Efficacy Parameters, Protocol Deviations
• Coding review trend analyses for safety parameters during the trial: Data clarification, SAE narrative writing and submissions, as well as regulatory SAE reconciliation and coding literature evaluations (scientific, efficacy, safety and competitive analyses)
• Complete safety database management to inform decisions in the near- and long-term