KCRN Research, LLC
KCRN Research is dedicated to providing flexible, sponsor-centered clinical and regulatory services for early phase drug development. With over 13 years of experience, they focus on delivering high-quality, cost-effective solutions tailored to each client's needs, emphasizing open communication, flexibility, and fixed-cost systems to ensure successful project completion.
Industries
Nr. of Employees
small (1-50)
KCRN Research, LLC
Germantown, Maryland, United States, North America
Products
In-house validated electronic data capture (EDC) system
An internally developed and fully validated EDC system used to capture and manage clinical trial data.
In-house validated electronic data capture (EDC) system
An internally developed and fully validated EDC system used to capture and manage clinical trial data.
Services
Integrated CRO services for pre-IND, IND, Phase I and early Phase II studies including project management, site management, data management, biostatistics, safety management and medical writing.
Gap analysis, pre-IND meeting preparation, IND filing (CTD/eCTD), orphan and fast track designation support, and ongoing FDA correspondence management.
Provision of sponsor-side personnel to act as extensions of sponsor teams for monitoring, project management and regional oversight.
Consulting on CMC requirements and management of contract manufacturing organizations to support clinical supply readiness.
Coordination or provision of analytical laboratory services to support safety assessments and bioanalytical testing during clinical studies.
Management of investigational product depot functions and distribution logistics for clinical trials.
Integrated CRO services for pre-IND, IND, Phase I and early Phase II studies including project management, site management, data management, biostatistics, safety management and medical writing.
Gap analysis, pre-IND meeting preparation, IND filing (CTD/eCTD), orphan and fast track designation support, and ongoing FDA correspondence management.
Provision of sponsor-side personnel to act as extensions of sponsor teams for monitoring, project management and regional oversight.
Consulting on CMC requirements and management of contract manufacturing organizations to support clinical supply readiness.
Coordination or provision of analytical laboratory services to support safety assessments and bioanalytical testing during clinical studies.
Management of investigational product depot functions and distribution logistics for clinical trials.
Expertise Areas
- Early-phase clinical trial management
- IND preparation and regulatory strategy
- Clinical data management and validated EDC
- Biostatistics and clinical analytics
Key Technologies
- Electronic data capture (EDC) systems
- eCTD/CTD regulatory submission format
- Clinical trial monitoring methodologies
- Clinical data management workflows
News & Updates
KCRN Research is collaborating with Elevai Biosciences to support their IND application to the FDA for the EL-22 myostatin treatment for obesity, aiming to start future clinical trials.
KCRN Founder & CEO Hugh Lee will be in South Korea until November 24, 2023, available for face-to-face meetings to discuss expanding into the US clinical research market.
KCRN Research working with non-profit Gfoundation to clothe underprivileged communities this winter.
KCRN founder Hugh Lee is working with Gfoundation to provide clothing to underprivileged communities in South Korea for the winter season.
KCRN Research won the Start-Up Business of the Year Award at the 2014 Montgomery County Small Business Awards.
KCRN Research is collaborating with Elevai Biosciences to support their IND application to the FDA for the EL-22 myostatin treatment for obesity, aiming to start future clinical trials.
KCRN Founder & CEO Hugh Lee will be in South Korea until November 24, 2023, available for face-to-face meetings to discuss expanding into the US clinical research market.
KCRN Research working with non-profit Gfoundation to clothe underprivileged communities this winter.
KCRN founder Hugh Lee is working with Gfoundation to provide clothing to underprivileged communities in South Korea for the winter season.
KCRN Research won the Start-Up Business of the Year Award at the 2014 Montgomery County Small Business Awards.