Guillermo B.

I help pharmaceutical sponsors, biotech companies, physicians, research sites, and academic investigators launch, operationalize, and scale clinical research programs with the rigor and compliance standards of leading academic medical centers. Over the past 10+ years, I have supported clinical research initiatives across Johns Hopkins University, the University of Louisville, and Mayo Clinic, working on industry-sponsored, investigator-initiated, drug, device, biologic, registry, and observational studies. My expertise spans clinical trial operations, study startup, regulatory support, REDCap development, scientific writing, grant development, and research infrastructure design. I provide practical, execution-focused support that helps research teams move efficiently from study concept to implementation. Unlike general research consultants, I bring hands-on experience working within highly regulated healthcare systems and collaborating directly with investigators, IRBs, sponsors, study monitors, and multidisciplinary research teams. SERVICES IRB Submission Support | Starting at $3,000 Preparation of submission-ready IRB packages, including protocol review, informed consent development, recruitment materials, regulatory documentation support, amendment preparation, continuing reviews, and study closeout support. REDCap Research Database Development | Starting at $2,500 Design and development of REDCap systems for clinical research, including longitudinal projects, automated survey distribution, participant-tracking workflows, branching logic, reporting tools, and data-export planning. Clinical Research Startup Support | Starting at $4,000 Support for investigators, clinics, and research sites launching studies, including feasibility assessments, startup strategy, site activation planning, workflow design, regulatory framework development, recruitment planning, and operational roadmaps. Research Operations Assessment | Starting at $2,000 Evaluation of existing research programs with workflow analysis, gap assessment, compliance review, process optimization recommendations, and actionable improvement plans. Scientific Writing Support | Starting at $3,000 Manuscript drafting, literature reviews, scientific editing, publication preparation, conference abstracts, research reports, posters, and medical writing support. Grant Development Support | Starting at $3,000 Specific Aims development, proposal drafting support, grant review and editing, literature synthesis, research strategy development, and scientific narrative refinement. AREAS OF EXPERTISE Clinical Trial Operations, Study Startup, REDCap Development, IRB Submissions, Regulatory Affairs Support, Research Operations, Site Activation, Multi-Site Studies, Data Collection Systems, Research Compliance, SOP Development, Scientific Writing, Grant Development, Protocol Development, Sponsor Coordination, Investigator-Initiated Studies, Industry-Sponsored Trials, Research Infrastructure Design. SELECTED EXPERIENCE 10+ years supporting clinical research programs in academic medical centers. Experience with drug, device, biologic, observational, and registry studies. Advanced REDCap architecture and database design. Multi-site research operations and coordination. Collaboration with investigators, sponsors, IRBs, FDA-regulated programs, NIH-funded projects, and study monitors. Research program development and operational infrastructure design. Leadership experience within Department of Medicine research initiatives. SELECTED SPONSOR EXPERIENCE Pfizer, Vanda Pharmaceuticals, Cook MyoSite, Alimetry, Neurogastrx, FoodMarble, electroCore (gammaCore Sapphire), Censa Pharmaceuticals, and Aclipse Therapeutics. WHO I WORK WITH Pharmaceutical Sponsors, Biotech Companies, Medical Device Companies, Academic Investigators, Physicians and Physician Scientists, Research Sites, Hospitals and Health Systems, Private Practices Building Research Programs, and Universities. Whether you need an IRB submission package, a REDCap database, research workflow optimization, manuscript support, grant development assistance, or operational guidance for a clinical research program, I would welcome the opportunity to discuss your project.