Services
Electronic REgulatory submissions
Submit eCTD-compliant US Investigational New Drug (IND) applications and Drug Master Files (DMFs) via the FDA's Electronic Submissions Gateway.
fda audit prep/follow-up & mock FDA Audit services
Prepare sponsor-investigators and clinical investigators for an FDA inspection, including offering mock audit services, and any requisite follow-up during and after an FDA inspection, including responding to any FDA Form 483s and/or FDA Warning Letters.
trial master file (tmf) document management
Assist with the management of all regulatory file documents across all sites for multi-center trials, from a site's study start up to eventual site close-out.
File management/document control management
Assist clients with creating or revising directory structures, document development processes, and document and report template designs.
discovery and Due Diligence assistance
Aid legal professionals in reviewing research records and other documents in connection with litigation, and evaluate study research records, reports, and source data in order to determine the quality of the intellectual property under review.
FDA IND/IDE sponsor-investigator SUBMISSION ASSISTANCE
Use customized regulatory-compliant document templates with excellent document management skills in order to collaborate with the relevant content experts to draft, compile, and manage US or CTD-based Sponsor-Investigator IND or IDE files.
CLINICAL TRIAL Auditing/monitoring
Conduct independent audits on any clinical study and also offer IND and IDE monitoring services for all FDA-regulated studies.
irb/dsmb review prep & assistance
Oversee completion of IRB applications and all subsequent submissions to the IRB and preparing the requisite data for any interim data safety monitoring board reviews of the study.
third party vendor qualification
Perform on-site inspections of third party vendors in order to ascertain capabilities and process standards.
education/curriculum development & speaking engagements
Develop client-tailored educational content and materials and present them in person or remotely via didactic or interactive formats. Session topics range from Adverse Event Reporting and Deviation Management, Clinicaltrials.gov Registration and Reporting, Good Clinical Practice, Informed Consent, FDA Inspections and Enforcement, In Vitro Diagnostic Device Regulations, and Sponsor-Investigator IND/IDE Responsibilities and Submission Processes.
FDA MEETINGs (pre-IND/IDE pre-sub)
Request meetings with FDA on sponsor's behalf and manage all meeting preparation/briefing package development and follow-up.
quality assurance (qa) department development
Assist clients with the development of a fully functioning QA department, including the development of an institution's data safety monitoring plan or QA department charter.
standard operating procedures (sop) development assistance
Work with your content experts to develop regulatory compliant standard operating procedures that reflect FDA regulations, state/local laws, and institutional policies.
site management assistance
Guide clients through the process of selecting research sites through pre-specified qualification criteria and offer assistance managing them from the time of study activation through termination.
Research ParticIpant Advocacy
Assist and empower individuals (and their families) who are considering whether or not to enroll on a research trial (or continue their trial participation on an existing study) via providing info on research ethics and the associated regulations that govern the human research enterprise.