Clinical Monitoring Research Program

COVID-19 clinical trials  

• Support several National Institute of Allergy and Infectious Diseases (NIAID) clinical trials evaluating safety and efficacy of novel therapeutic agents to treat patients infected with COVID-19.   
• The Adaptive COVID-19 Treatment Trials (ACTT), which was the first clinical trial in the United  States  to evaluate  an experimental treatment for SARS-CoV-2. The study found the antiviral remdesivir accelerated recovery for COVID-19 patients.  
• The Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) study, which evaluated the combination of remdesivir and a highly concentrated solution of antibodies that neutralize SARS-CoV-2.  
• The monoclonal antibody study known as ACTIV-3/TICO, assesses whether new treatments are effective against COVID-19.  
• Facilitate coordination and management of multi-site activities, regulatory inspections and approvals.  
• Monitor clinical trial sites, manage research subcontractors, and coordinate logistics/shipping of materials and supplies.  
• Facilitate launch of studies using INSIGHT network, prepare regulatory submissions, translate documents, manage research subcontractors, and provide medical monitoring support.

Ebola clinical research  

• Support PREVAIL clinical research studies in Liberia, Guinea, Sierra Leone, and Mali.  
• Enhance clinical research capacity in West Africa and the Democratic Republic of the Congo.  
• Renovate facilities, improve infrastructures, and provide training opportunities for local staff.  
• Support operational and logistical needs through procurement, shipping, inventory management, and travel coordination.  
• Provide IT support by building infrastructure, optimizing internet connectivity, and creating a social analytics platform.  
• Support study goals to better understand the Ebola virus, therapeutic options, and vaccine safety and efficacy.  

Brain Tumor Trials Collaborative  

• Provide the National Cancer Institute's Brain Tumor Trials Collaborative with clinical and administrative infrastructure support to the network of 30+ medical centers participating in the collaborative investigating new treatments for malignant brain tumors and rare adult central nervous system cancers.  
• Assist with protocol development/navigation.  
• Coordinate communications for the collaborative.  
• Manage subcontracts for drug distribution and lab analysis.  

Project and program management  

• Manage domestic, international, single-site, and multi-site clinical research programs.  
• Provide rapid response to urgent clinical research initiatives.  
• Foster collaborations with internal and external organizations.  
• Organize and implement program management infrastructures.  
• Provide technical project management of research subcontracts.  
• Support correlative studies through collaborative research and development agreements.  
• Provide procurement and supply chain management for office and laboratory equipment, materials, and supplies.  
• Coordinate events/meetings, manage travel logistics.  
• Facilitate logistical support for shipping pharmaceuticals and clinical research materials.  

  Clinical trials management  

• Facilitate and manage domestic and international clinical research studies and investigational new drug trials.  
• Conduct pre-study site assessments, site initiation visits, site monitoring, and study close-out visits.  
• Provide protocol training to clinical research sites.  
• Design, prepare, submit, distribute, and track essential study documents.  
• Track study agents.  
• Ensure compliance with the research protocol, ICH/GCP guidelines, and applicable regulations.  
• Facilitate communications between the clinical research sites and IND sponsor entities.  
• Coordinate investigator meetings.  
• Prepare for the U.S. Food and Drug Administration and drug-sponsored audits.  
• Develop case report form templates and load them into databases.  

Clinical research team support  

• Support National Institutes of Health clinics and program initiatives.  
• Provide clinical research professionals for direct patient care and research support.  
• Support research subject recruitment, schedule patient appointments, create clinic schedules.  
• Provide bioinformatics support, statistical support, mathematical programming, and imaging informatics support.  
• Coordinate and perform clinical research protocol responsibilities related to research participants.  

Protocol navigation, development, and coordination  

• Streamline clinical research protocol writing and approval processes.  
• Function as liaison between customers and review offices.  
• Navigate investigators through regulatory and administrative requirements for protocol submission.  
• Collect metric data, track milestone dates, categorize and respond to Institutional Review Board  stipulations.  
• Provide administrative coordination to support regulatory activities.  
• Coordinate protocol review submissions.  

Pharmacovigilance  

• Promote protection of clinical trial participants.  
• Perform protocol safety oversight and review safety data.  
• Evaluate safety data and reportability to the U.S. Food and Drug Administration.  
• Coordinate and manage Data Safety and Monitoring Boards.  
• Prepare safety reports. 

Regulatory affairs expertise  

• Prepare, submit, and maintain compliant regulatory applications (INDs, CTAs, IDEs, DMFs).  
• Conduct regulatory review of clinical protocols, informed consent documents, and other clinical documents.  
• Act as regulatory liaison with trial sponsors, the U.S. Food and Drug Administration, and regulatory bodies.  
• Offer regulatory strategy and support to investigator.  
• Provide current good manufacturing practice guidance on product storage, shipping, labeling, and manufacturing issues.  

Learning and professional development

• Provide continuing education and customized training events to directorate staff and government customers.  
• Address required regulatory, technical, and professional skills competencies.  
• Conduct training needs assessments and respond to training needs.  
• Identify, develop, and facilitate professional development opportunities.  

 Information technology support and clinical data management 

• Manage IT solutions, support business continuity, and provide user support.  
• Develop websites and databases.  
• Customize enterprise applications.  
• Create and maintain clinical trial summary records.  
• Perform clinical data abstraction, curation, and management.  
• Determine data management and IT requirements at clinical sites.  
• Establish validated data flows and provide data management training.  
• Support database locking and data archiving. 

Support to additional institutes