We are a full service Global Clinical Business Development, Operations, Management, and Research company. Serving the Patients is the core of our company’s culture. Our specialty is to custom design our care according to the needs of our clients, and their business model.
Our core competencies are CNS and Oncology. We are experienced in global multi-center studies in hematology, Alzheimer’s Disease, Schizophrenia, Parkinson’s and ADHD, as well as in Cardio Vascular, and Men’s Health, Phases I – III and post approval trials. Our DMC group has many years of experience in hematology. We have conducted clinical studies of lymphoma, and non-Hodgkin’s lymphoma (NHL), with the focus on registration and phase II trials in
lymphoma and solid tumors.
We have at our disposal a collection of the best, the brightest, and the most diverse Researchers, Physicians, Nurses, Statisticians, Project Managers, Regulatory specialists, IT and Business Development Professionals to ensure results and unsurpassed quality of service to our clients. We have international scientific, business and cultural experience, as well as access to niche markets.
We pride ourselves in integrity, precision and dedication, and our mission is to provide world class Clinical Research Services, Regulatory Submissions, Business Development, Operations, and Management expertise to our clients, and partners in trade.
Our specialty is to custom design our care according to the needs of our clients, and their business model.
Clinical Research Management
We work with clients from the beginning, with sites evaluation and selection, protocol development, eCRF design, regulatory documents preparations and submissions, patient recruitment, clinical project management, monitoring, safety and pharmacovigilance, as well as close out procedures, statistical analysis, medical writing and CSR reporting.
Clinical Data Management
We offer complete CDM solutions, such as eCRF design and maintenance, interim CDM data cleanup and queries resolution. We bridge the gap between sponsors and clinical sites, to ensure data integrity and availability.
Regulatory and Ethics Committee Submissions
We create a comprehensive Regulatory calendar to ensure timely Regulatory documents preparations, and submissions. We ensure all Ethics Committee (EC), Institutional Review Board (IRB), and Competent Authority documents are prepared and submitted on time.
In addition, we work with the sponsor, to draft Inform Consent Form(s) for each study. By providing central IRB services to our clients, we ensure the expedited IRB reviews of multi-center clinical research projects. We support most independent monitoring committees, such as independent DMC, DSMB, Clinical Events Committee (CEC), clinical trial steering committees, and adjudication panels, to ensure complete compliance with FDA guidelines
We strive to enhance our services continuously in order to best support scientifically sound, and ethically valid clinical research programs.
Business Development and Operations
We ensure all aspects of your molecular development is in line with your company’s mission statement. We offer Strategic Planning, comprehensive Project and Program Management, Best Practices Optimization and Cost Containing Measures.
Reserch and Development
We are able to help companies manage high throughput molecular screening and target selection, including macro molecule crystallization and structure guided drug design.
Pre-clinical / Clinical Pharmacology
We assist you with designing pre-clinical, formulation, and initial toxicology studies, in preparation for clinical pharmacology trials, including First in Human studies.
KamGen Consulting Inc. is dedicated to seek and retain exceptional talent in support of professional and personal growth and fulfillment. We offer an energetic, highly positive, result driven work environment that values team work and customer satisfaction above all. If interested, please submit your resume, along with a cover letter.