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    Health (Clinical Trials)

 

  • Extensive experience with domestic and international clinical trial regulations.

 

  • Drafted, negotiated and managed agreements, amendments, templates, subcontracts and related ancillary documents for industry-funded clinical trials on behalf of pharmaceutical clients, sponsors and community participants.

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  • Compliance with the European Medicines Agency (EMA) Policy 0070 (Publication of Clinical Data and Reports).

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  • Compliance with Food and Drug Administration (FDA) application requirements – abbreviated new drug application (ANDA), experimental investigational new drug (EIND) application, investigational new drug (IND) application and new drug application (NDA) – FDA operating guidelines – such as current good manufacturing practice (cGMP), good clinical practice (GCP), good laboratory practice (GLP), good manufacturing practice (GMP) – European Medicines Agency (EMA) marketing authorisation application (MAA), International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use common technical document (CTD) requirements. 

 

  • Liaison with related internal departments, such as risk management, accounting, operations and management.

 

  • Experience with clinical research science and processes, drug development process and product development processes.

 

  • Legal support for all clinical trial phases (I-IV).

 

  • Legal support for domestic and international investigator sites, site management organizations (SMOs), contract research organizations (CROs), and academic research organizations (AROs).

 

  • Participated in the development team for clinical site agreements (CSAs), to identify specific legal goals and strategies.

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  • Legal support for all payments to vendors and study sites, and for claims and disputes arising therefrom.

 

  • Legal support for the formulation of site start-up (SSU) requirements including facilities, deliverables and staffing, and monitored legal issues involved with clinical trial management system (CTMS) tracking requirements.

 

  • Developed country-specific CSA and clinical trial agreement (CTA) templates with input from relevant CSA team members, including clinical trial specialists (CTSs), clinical research associates (CRAs), project leaders (PLs), global regulatory operations (GRO) liaison and sponsor, drafted, negotiated and administered project-specific revisions, amendments and addenda, for all studies within various small-scale and large-scale projects.

 

  • Developed and maintained a database of all CSA, CTA, and other templates and executed agreements.

 

  • Provided legal support to the study team through correspondence, requests for proposals (RFPs), requests for qualifications (RFQs) and interview sessions, to select potential investigators and assess their interest in the study.

 

  • Communicated with sites regarding legal issues, progress and compliance with applicable laws and site protocols.

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  • Review, distribution and management all legal documentation for studies, including document database.

 

  • Extensive research on the US National Library of Medicine clinicaltrials.gov website.

 

  • Experience in the execution of clinical research trials, including good clinical practice (GCP), regulatory guideline knowledge and audit inspections, and change management initiatives.

 

  • Legal support for clinical study budgeting, including the application of clinical trial performance metrics and timeline.

 

  • Legal support for the development and application of standardized methodologies, operational study processes, and quality and performance metrics.

 

  • Audits to promote continuous process improvement, best practices and effectiveness across clinical operations.

 

  • Management of the legal aspects of the operational study plan (such as start-up, conduct, close-out, and vendor oversight), timelines, and risk mitigation processes with input and collaboration from all key stakeholders.

 

  • Working knowledge of various quality management systems and extensive experience with regulations in the medical device and pharmaceutical industries.

 

  • Extensive experience testing, using, recommending and procuring working with numerous electronic document management (EDM) systems, templates, tracking logs and cloud-based databases.

 

  • Training for all levels of personnel on clinical-trial-related document control practices, protocols and procedures.

 

  • Understanding of the Growth Product Flow (GPF) Governance Board model for project management and operations.

 

  • Responsible for legal oversight of clinical trial registrations and results postings on clinicaltrials.gov, the European Union Clinical Trial Register (EUCTR), European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) European Union Electronic Register of Post-Authorization Studies (EUPAS).

 

  • Prepared reports, strategic plans, informational materials, guidelines and budgets for domestic and international records management and records retention efforts related to compliance.

 

  • Implemented and maintained the database of corporate personally-identifiable information (PII).

 

  • Legal oversight and support for initiatives involving expanded access to experimental biologics (“compassionate use”) outside of the standard clinical trial process.​

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  • Legal and administrative support for Site Start Up (SSU) activities, such as: assisted with the planning, preparation and on-site support of investigators meetings; collected and tracked patient enrollment information; feasibility studies (ensured that all study-related regulatory and financial documents were collected and reviewed in support of the study activation); document filing and organizing;generated reports and applications to assist in performing clinical data review; interacted with institutional review boards (IRBs) and outside vendors to provide information and resolution for specific requests; maintained, organized and tracked critical documents and project working files; participated in testing electronic data capture (EDC) and interactive voice response systems (IVRSs) and web response systems (IWRSs); preparation and distribution of meeting agendas and minutes; reconciled and transmitted all required essential documentation to the Center for Disease Control (CDC), FDA and the Chronic Disease Innovation Centre (CDIC) in Canada; reported discrepancies to the appropriate clinical team member; supported the regional site managers by providing study-related information tracked the processing of payments; updated study management reports.

 

  • Provided training in the legal aspects of studies and trials to new clinical trial associates (CTAs) and clinical scientists (CSs).

 

  • Compliance with cGMP, GCP, GLP and GMP audit procedures as prerequisites to commercializing the biologic, medical device or pharmaceutical product.

 

  • General preparation for audits includes reviewing past audit and FDA inspection results, including all operations that the enterprise has outsourced, identifying the standard operating procedures (SOPs) that are relevant to the particular process at issue, and establishing a specific agenda that includes timelines personnel required to support the audit.

 

  • cGMP and GMP (the FDA apparently added the “c” – for “current” – to “GMP” in recent years to emphasize the rapidly-evolving practices involved in manufacturing and the necessity for all manufacturers always to keep current) are applicable to manufacturing, packaging and processing operations, after successful clinical and nonclinical testing of the subject product.

 

  • Familiarity with the basic types of cGMP/GMP and inspections: for-cause/directed (due to drug contamination or complaint); pre-approval of product; product surveillance; and, post-approval of product.

           

  • Responses to warning letters resulting from cGMP/GMP FDA audits, regarding infractions, such as insufficient batch control records, lack of documentation deficiencies and microbiological contamination.

 

  • Particular emphasis during cGMP/GMP audits on the typical subsystems in the audit process: facilities and equipment; labeling and packaging; laboratory controls; materials; and, production.

 

  • GCP has the main goal of the health, safety, and rights of the human study participant, and must result in documentary evidence that on balance the product produces more benefits to humans than detriments.

 

  • GCP requires that the study participant must provide “informed consent” in order to be included in the study, so the study participant must be informed in advance of all the applicable study health and safety protocols and standard operating procedures (SOPs), as well as any known areas of concern.

 

  • Monitored clinical trial activities outsourced by the sponsors, such as clinical research organizations (CROs).

 

  • GLP audits focus on nonclinical laboratory testing environment and materials, and are required for obtaining premarket approval of regulated products from the FDA.

 

  • Compliance with GLP is critical to the success of a study, because the FDA can disqualify testing facilities for failure to comply with one or more regulatory mandates, non-compliance which negatively impacts study quality or validity, or any other lesser regulatory issues such as corrective actions are inadequate in achieving compliance.

 

  • Use of third-party audit firms to conduct GLP audits in the time periods between the mandatory maximum 2-year FDA audit periods.

 

  • Legal support for all risk management activities involved with the GLP external service provider (ESP), for research and development (R&D) and outsourced GLP-related work.

 

  • Responsible for identification and mitigation of external service provider issues, internal GLP-related processes and proactive risk identification involving business partner operations, such as bioresearch quality and compliance, biotherapeutics, discovery sciences, ecotoxicology, environmental health and safety, nonclinical safety, plant and materials protection, viral vaccines.

 

  • Review of any systemic risks related to GLP quality management systems or the oversight processes.

 

  • Interaction with various cross-functional preclinical development teams, regarding the assessment of any identified risks and the development of risk mitigation strategies.

 

  • Ensured appropriate risk monitoring, oversight and communication.

 

  • Identified key risks and formulated risk management mitigation plans.

 

  • Legal support for the development of the master audit schedule and GLP audit schedules.

 

  • Established key performance indicators (KPIs) for the assessment and qualification of future GLP ESPs.

 

  • Legal support for corrective and prevention action (CAPA) development in the risk management strategy.

 

  • In depth knowledge of the Organisation for Economic Co-operation and Development (OECD) GLP-related guidelines.

 

  • Familiarity with different GLP study types in global multisite studies, such as for bioanalysis, genetic toxicology, pathology, toxicokinetics, toxicology.

 

  • Legal support for health economics and outcomes research (HEOR).

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  • Legal support for clinical studies.

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  • Evaluation, testing, use and recommendation for the selection of, sourcing and procurement of clinical trial management system (CTMS) platforms to track study progress, including patient enrollment and patient status, such as Castor EDC, ClinCapture, Clinical Conductor CTMS, Clinical Studio, Clinical Trials Management, Dacima Clinical Suite, Ennov CTMS, MasterControl Clinical Suite, Medrio, OpenClinica, RealTime-CTMS, Smartsheet.

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  • Research, testing, use, recommendation, specification and procurement of various desktop publishing (DTP) platforms, such as Adobe InDesign, Microsoft Publisher, QuarkXPress, Scribus and Xara.

 

  • Research, testing, use, recommendation, specification and procurement of various document management systems (DMSs), such as Bitrix24, Box, Bynder, Confluence, Dropbox Business, eFileCabinet, GoCanvas, Google Drive, HoudiniESQ, LibreOffice, Microsoft OneDrive, Notion, ONLYOFFICE, PandaDoc, Priority Matrix, Process Street, Quip, Samepage, ShareFile, Suralink, Widen Collective, Wrike.

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    Last updated 210509_1345

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