Giving Flexibility to Early Phase Clinical Trials!!

We are committed to providing clinical and regulatory services that are specifically tailored to meet your needs.

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Sponsor Centered Operation Services

The way we operate reflects our main objective: successfully carrying out and completing each project with a Sponsor-centered mindset.

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Fixed cost & Incentive system!

We always operate as part of your team. Even in unexpected and unfavorable situations such as project delay or other undesired results.

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About Us

Giving Flexibility to Early Phase Clinical Trials!

About Us

Proactive, motivated, and focused

KCRN Research is committed to providing clinical and regulatory services that are specifically tailored to meet your needs. We are focused on addressing the need for an efficient and cost-effective path to drug development. Our unique approach shows that we strive to share the common goal of a swift and smooth entry into the clinical trial process with our clients. In other words, we make your success our highest objective.

We consider ourselves an extension of your team and will engage in your projects with an attitude that is aligned with yours. In other words, we operate with a Sponsor-centered mindset.

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More Information about KCRN

Person

Company History

For the past 12 years

From the beginning, we’ve had a Sponsor-like mindset as our focus. The Founder of KCRN, before starting the company in early 2012, has had extensive experience on the Sponsor-side of the industry as a clinical and regulatory project manager within various pharmaceutical companies. As the primary contact with the CROs involved in his projects, he gained insight on the limitations of the Sponsor-CRO relationship. He experienced first-hand how often CROs sidestep the partnership during delays and readily take advantage of any opportunities to increase the budget. And he saw the need for a CRO that can deliver both quality and cost-effectiveness together in a way that provides an overall satisfying experience for everyone involved.

Utilizing his expertise, he then set out to create a firm that evolves the Sponsor-CRO relationship to provide the highest level of quality service while preserving cost-efficiency. Today, we operate with that same belief; keeping the interests of the Sponsor in mind within every step of our operations by applying our unique knowledge and proficiency.

Person

Our Expertise

To help you better

With the KCRN methodology of operations, we are ready to handle any early phase drug development project that might come our way, regardless of the indication of the drug. Our team is committed to ensuring that your project is done with the highest quality in capable hands.

Indication Pre-IND IND Phase 1 Phase 2
Solid Tumor ✓ ✓✓✓✓✓✓ ✓✓✓
Myelodysplastic Syndrome ✓ ✓
Breast Cancer ✓✓ ✓
Glioblastoma ✓ ✓
Hepatocellular Carcinoma ✓
Lung Cancer ✓✓
Head and Neck Cancer ✓✓ ✓
Ulcerative Colitis ✓✓✓✓ ✓✓ ✓
Alzheimer’s Disease ✓✓ ✓✓✓✓ ✓ ✓
Parkinson’s Disease ✓ ✓ ✓
Major Depressive Disorder ✓ ✓
Amyotrophic Lateral Sclerosis ✓ ✓
Cerebral Palsy (Non-US) ✓
Charcot-Marie-Tooth Disease ✓
Duchenne Muscular Dystrophy ✓
Idiopathic Pulmonary Fibrosis ✓ ✓
Pneumonia ✓ ✓
Bronchopulmonary Dysplasia ✓ ✓
Tuberculosis ✓ ✓✓
Type 2 Diabetes ✓
Diabetic Retinopathy ✓
Diabetic Neuropathy ✓
Diabetic Macular Edema ✓✓ ✓ ✓✓
Age-related Macular Degeneration ✓ ✓
Thyroid Eye Disease ✓ ✓
Osteoarthritis (Cartilage Defects) ✓✓✓✓ ✓✓
Post-operative Pain ✓ ✓ ✓
Spinal Cord Injury ✓
Atopic Dermatitis ✓ ✓✓✓✓ ✓ ✓✓
Erectile Dysfunction ✓ ✓
Hepatitis C ✓
Graft versus host Disease ✓ ✓
Hypertension ✓✓ ✓✓
Bioequivalence, Medical Device ✓✓

Pre-IND Projects: Buerger’s Disease, Traumatic Brain Injury, Bechet's Disease, Hunter Syndrome, Duchenne Muscular Dystrophy, Anthrax
Updated as of September 1, 2022

Person

News & Events

What's new
(2024-10-22) KCRN Research working with Elevai Biosciences in support of IND application approval with FDA
KCRN Research is pleased to announce that we will be working together with Elevai Biosciences, a subsidiary of Elevai Labs, Inc. makers of the popular Elevai Skincare products, to spearhead their efforts in bringing their novel EL-22 myostatin treatment for obesity without the muscle loss normally seen in other GLP-1 weight loss treatments to the US Food & Drug Administration with a possible IND application and with the hopes of starting future clinical trials.

For more information:

https://www.globenewswire.com/news-release/2024/10/22/2967072/0/en/Elevai-Biosciences-a-Subsidiary-of-Elevai-Labs-Inc-Engages-Leading-Contract-Research-Organization-CRO-to-Support-Regulatory-Planning-Efforts-and-Pre-IND-Meeting-with-the-Food-and-D.html

(2023-10-23) KCRN CEO Hugh Lee will be available for face-to-face meets in South Korea
KCRN Founder & CEO will be in South Korea until November 24, 2023 and will be available for any face-to-face meetings from any interested parties looking towards expanding into the US clinical research market.

Please contact us at info@kcrnresearch.com for any and all questions or inquiries! We hope to meet you soon!

News & Events List

Date Subject Contents
2024-10-22 KCRN Research working with Elevai Biosciences in support of IND application approval with FDA KCRN Research is pleased to announce that we will be working together with Elevai Biosciences, a subsidiary of Elevai Labs, Inc. makers of the popular Elevai Skincare products, to spearhead their efforts in bringing their novel EL-22 myostatin treatment for obesity without the muscle loss normally seen in other GLP-1 weight loss treatments to the US Food & Drug Administration with a possible IND application and with the hopes of starting future clinical trials.

For more information:

https://www.globenewswire.com/news-release/2024/10/22/2967072/0/en/Elevai-Biosciences-a-Subsidiary-of-Elevai-Labs-Inc-Engages-Leading-Contract-Research-Organization-CRO-to-Support-Regulatory-Planning-Efforts-and-Pre-IND-Meeting-with-the-Food-and-D.html
2023-10-23 KCRN CEO Hugh Lee will be available for face-to-face meets in South Korea KCRN Founder & CEO will be in South Korea until November 24, 2023 and will be available for any face-to-face meetings from any interested parties looking towards expanding into the US clinical research market.

Please contact us at info@kcrnresearch.com for any and all questions or inquiries! We hope to meet you soon!
2023-10-20 KCRN Research working with non-profit Gfoundation to clothe underprivileged communities this winter. KCRN Research is proud to announce that KCRN founder, Hugh Lee, is working with Gfoundation international non-profit organization based in South Korea to provide clothing to the underprivileged for the upcoming winter season and beyond.

https://gfound.org/bbs/board.php?bo_table=company_2022&wr_id=263&page=17

Gfoundation is a Christian non-profit that provides welfare and social development projects to underdeveloped communities in South Korea and globally around the world.

https://gfoundationus.org/

We thank Gfoundation for all the good works that they do in helping those in need as KCRN Research looks toward the second step planned to help more people this winter.
2023-10-20 KCRN Research working with non-profit Gfoundation to help clothe underprivileged communities this winter. KCRN Research is proud to announce that we are working with Gfoundation international non-profit organization based in South Korea to provide clothing to the underprivileged for the upcoming winter season and beyond.

Gfoundation is a Christian non-profit that provides welfare and social development projects to underdeveloped communities in South Korea and globally around the world.
2023-10-20 KCRN is working with Gfoundation to provide clothing to the underprivileged this Winter. KCRN Research is proud to announce that we are working with Gfoundation international non-profit organization based in South Korea to provide clothing to the underprivileged for the upcoming winter season and beyond.
2022-10-07 Hugh Lee of KCRN Research concluded a successful KSNS 42nd Workshop event in South Korea with a seminar presentation. The Korean Society for Non-Clinical Studies 42nd Workshop titled - The Multiverse of New Therapeutics via Emerging Biotechnologies - has just concluded. KCRN Research and QuBEST BIO were presenters of the second day Luncheon Seminar #1.

Thank you to all who attended!
2022-09-02 KCRN & QuBEST BIO at the 8th Annual KoNECT-MOHW-MFDS International Conference Oct 12 - 14 KCRN and QuBEST BIO will be attending the 8th Annual KoNECT-MOHW-MFDS International Conference hosted jointly by the Korean National Enterprise for Clinical Trials, the Korean Ministry of Health and Welfare and the Korean Ministry of Food and Drug Safety.

Come visit our booth and discuss with us about various tailored clinical solutions that fits you.

Topic: Connecting Tomorrow Therapeutics to Patients
Date: October 12 - October 14, 2022
Venue: Conrad Hotel, Seoul, South Korea
2022-06-15 KCRN & QuBEST BIO will be particpating in The 20th InterBiz Bio-Partnering & Investment Forum 2022 Join us at our exhibitor booth at the conference in Jeju, South Korea!

https://www.interbiz.or.kr/interbiz

Meet experts in each field from both early development clinical CRO KCRN Research and non-clinical CRO QuBEST BIO to discuss the next stage of drug development and promote global clinical trials.



< QuBEST BIO와 KCRN Research가 제20회 인터비즈 바이오 파트너링 & 투자포럼 2022에 참가합니다>
https://www.interbiz.or.kr/interbiz/
✔️ 비임상 전문 CRO QuBEST BIO와 초기 임상 전문 CRO KCRN Research가 함께합니다.
✔️ 각 분야의 전문가들을 만나 신약 개발의 다음 단계를 논의하고 글로벌 임상을 도모하세요
2021-11-18 KSMS 40th Annual WORKSHOP Program of the Korean Society for Non-Clinical Testing and Research! Date: December 16, 2021
Venue: Suwon Convention Center Convention Hall
Topic: Dynamically Growing K-Bio Pharm in 2021

We welcome you to join us in the workshop event as we go over the successes that the Korean Bio and Pharma communities have already accomplished and discuss areas of needed improvement as well as further avenues for growth.
Come stop by our booth and meet with us to talk about opportunities in your drug development plans. Our approach has always been to not just find the right solutions, but the right solutions for you.
2020-10-12 KCRN Hyungjoo (Hugh) Lee (CEO & Founder) presents a sharing seminar KCRN Research CEO & Founder Hyungjoo (Hugh) Lee will be presenting a special virtual seminar this October 20, 2020 at 9 am Korea Time (Oct 19, 8 pm Eastern Time) titled 'Practical Aspects of Conducting Early Phase Clinical Trials in the United States' on the KIOSC Training online platform. Registration for this seminar is free and open to all who wish to gain a basic understanding of the processes that go into the critical early stages of clinical trials inside the largest market in the world.
2020-10-05 KCRN Research has new address KCRN Research is relocating to a brand new home at 12311 Middlebrook Rd. Suite 200, Germantown, MD 20874. There are a lot of fond memories at our previous location where KCRN Research really grew as an organization, but it is also exciting to enter a new chapter for our company and see what the future holds for us.
2020-09-16 KCRN Presentation at KAPAL 2nd On-Air Webinar Joseph Hong (Business Development) of KCRN Research spoke at the KAPAL 2nd On-Air Webinar that focused on the growing partnership between South Korea's and the state of Maryland's life science communities. The presentation included an introduction to the clinical CRO company as well as the opportunities that the Maryland life science environment has given companies like KCRN and for any others interested in doing business inside it.
2017-03-27 BioKorea 2017 International Convention We have a plan to participate for three days (Apr 12-14, 2017) in the BioKorea International Convention with pharmaceutical and biotechnology companies. Please stop by at our booth to learn more about KCRN Research.

KCRN Research will be available in South Korea Apr 10, 2017 to Apr 20, 2017 for meetings with Sponsors in Korea who are looking for the opportunity to develop drugs in the United States. We will be happy to consult with you to address your goals and the possibility of working with KCRN. Please contact Hugh Lee (hughlee@kcrnresearch, 301-540-2600 or 240-421-3190) or Jae Kim (jaekim@kcrnresearch.com, 240-277-9983) to make an appointment.
2014-05-22 2014 Montgomery County Small Business Award We are very proud to announce that KCRN Research won the Start-Up Business of the Year Awards at the 2014 Montgomery County Small Business Awards. We have come a long way since we started in 2012 and we would like to take this time to thank our partners and clients who have continued to put their trust in our business.

Congratulations to the other winners at this event. For the full list of winners, please click here.
2014-04-14 2014 Annual Korean Marketing Events We are currently preparing for an event-packed summer in Korea to meet potential clients and promote the services that we have to offer. We hope to meet pharmaceutical and biotech companies who are interested in the KCRN way of early phase clinical development of world-changing drugs.

2014 Korean Society of Biochemistry and Molecular Biology (KSBMB) Annual Meeting
We are attending the 2014 KSBMB Annual Meeting on May 15-16, 2014 at Booth #3 to meet with those interested in a cost-effective and efficient entry into early phase clinical trials. We hope to meet you there!

BioKorea 2014 International Convention
We look forward to spending a wonderful three days (May 28-30, 2014) in the BioKorea International Convention with pharmaceutical and biotechnology companies. Please stop by at our booth to learn more about KCRN Research.

KCRN Research will be available in South Korea June 13, 2014 to July 12, 2014 for meetings with Sponsors in Korea who are looking for the opportunity to develop drugs in the United States. We will be happy to consult with you to address your goals and the possibility of working with KCRN. Please contact Hugh Lee (hlee@kcrnresearch, 301-540-2600 or 240-421-3190) to make an appointment.
2013-10-23 New Fall 2013 Marketing Campaign Hello from KCRN Research!

We would like to inform you that we have started a new marketing campaign featuring a variety of our clinical and regulatory services as well as competitive biotechnical and animal study services from two of our partnering biotechnology companies. With our collaborative efforts for a better quality and higher efficiency, we are proud to say that we make a wonderful package. Wherever you are on your journey to drug development, you will find that we offer the services that directly meet your needs.

Our marketing campaign includes:

KCRN Research (www.kcrnresearch.com)
Practical and efficient clinical and regulatory services in early phase drug development from a sponsor’s point of view
Curachem (www.curachem.com)
High quality custom carbon-14 radiolabeling and stable isotope labeling to support your research and development programs
Korean Institute of Toxicology (www.kitox.re.kr)
Comprehensive and cost-efficient non-clinical safety studies to ensure a speedy and reliable entry into clinical trials

For more information about each of our featured companies, contact us at kchoe@kcrnresearch.com or 301-905-8989. We will be happy to talk with you more about the particular services that may fit your company’s needs.
2013-10-14 Renovated website newly opened! Hello from KCRN Research.

As you may have noticed, we have completely renovated our website and updated all our posts!
We are thrilled to say that our website now reflects KCRN more accurately.

We are committed to effective communication. If you have any questions, please contact us at bd@kcrnresearch.com or 301-540-2600.

Thank you for your interest in KCRN Research.



KCRN Methodology

We do things differently here!

As a company providing services in the complex and demanding world of pharmaceuticals, we often think about how we could accommodate both quality and efficiency. We have found that this achievement requires the ability to be flexible while still preserving our uncompromising commitment to excellence. As a result, we have developed a revolutionary way of delivering dependable and satisfying services to our clients. This is our new perspective, the KCRN’s way of doing things:

Low Cost, High Efficiency

We understand your needs for a swift and smooth entry into clinical trials. Many contract research organizations, however, include unnecessarily complicated systems and large project teams that seem essential for guaranteeing success but are actually irrelevant to the success of the project. These “features” serve to give the impression that the CRO is focused on quality, giving them a way to justify a higher service cost. At KCRN, we have moved away from this pattern and reconstructed a system which allows us to provide the services that are essential to delivering quality and efficient results, while eliminating noncompulsory additions of services and team members that increase the budget and timeline. The result is a service specifically tailored to fit your needs. At the end of the day, you will find that we provide quality service with a higher efficiency and for a lower cost.

Sponsor Centered Operation Services

The way we operate reflects our main objective: successfully carrying out and completing each project with a Sponsor-centered mindset. By doing so, we ensure that our operations are executed with maximized efficiency and quality. To achieve this, we look for the most pragmatic and strategic way of undertaking a project, cutting out all the excess steps and complexities that delay the timeline and do not add value or quality. One way in which we accomplish this is by bringing together the most suitable people for each area of expertise required for each specific project. Whether it is one of our highly trained team members or an external expert, you can be confident that your project is in good hands.

Fixed cost & Incentive system

We take responsibility for our work. Literally. We offer fixed costs for our services because we understand that there are highs and lows within each project. In other words, KCRN Research is a willing member of your team, even in unexpected and unfavorable situations such as project delay or other undesired results. We are only satisfied when the Sponsor is satisfied, and in doing so we have accumulated many true win-win situations. We aim to keep our word, no matter the situation. And with our incentive system, we can prove to you just how motivated and serious we are about keeping our word.

Our Services

We are committed to meeting your needs.

In the early phase of drug development, KCRN offers various and customized clinical and regulatory services to provide a comprehensive partnership for the special needs of your specific project. The services we provide are the collaborative efforts of our capable project team members. Our unique approach to projects, the KCRN way, is the direct outcome of our work philosophy: to share in the responsibilities and obligations of the sponsor and to have a sponsor-like attitude toward the project.

We know every project has its own challenges. And we strive to meet those challenges by facilitating the Sponsor-CRO relationship with the following:

Open communication

We promote effective external and internal communication to ensure the Sponsor and KCRN alike are on the same page at every step.

Flexibility

We are there as an extension of your team during all the ups and downs within the life cycle of the project. We are quick to shift, adjust, and advance in order to maintain a consistent focus while keeping the project on track.

Customization

Our operations are Sponsor-centered. Therefore, we customize each project so that every aspect of it is specific to the needs of each Sponsor and the Sponsor’s project. Every task has a purpose, and every operation is structured around your project.

Clinical Services

We provide clients full CRO services with our preferred partners and vendors. In particular, our unique CRO services based on the KCRN Methodology are beneficial to small and mid-size pharmaceutical/biotech companies who have limited clinical experiences and seek flexibility in budget, timeline, and operations.

Our CRO services include:

  • Project management
  • Site management (e.g., Site monitoring)
  • Data management
  • Biostatistics
  • Safety Management
  • Medical writing
  • Safety / Analytical lab
  • Drug depot

In addition, we offer the following customized services to our clients according to their various needs

To pharmaceutical/biotech companies:

  • Sponsor Project Manager
  • Sponsor CRA
  • CMC Development Consulting
  • CMO Management

To services providers:

  • Regional CRA
  • ePASS EDC system (Developed in-house and fully validated)
  • Service marketing (by KCRN M&C)

Regulatory Services

The KCRN team of regulatory services take on a collaborative and coordinated approach so that all the components of our services are carefully planned out in a pragmatic and strategic way. One of the advantages of using our regulatory services is that we utilize our network of expert specialists so that each task is in the most capable hands.

Our regulatory services include:

  • Gap Analysis
  • Pre-IND meeting
  • Scientific Advisory Board (SAB) Formation
  • Protocol development
  • IND filing and follow-up (CTD / eCTD)
  • Orphan drug designation
  • Fast track designation
  • Other FDA correspondences (Safety reporting, etc.)

Global

Giving Flexibility to Early Phase Clinical Trials!

“KCRN Research is currently expanding its global reach. We have worked in the past with pharmaceutical companies in Asia and Europe, and participated in clinical and regulatory affairs in the global context. From serving as the local agent to providing full CRO service, we have the right strategy and expertise in place, to take on whatever tasks, with which we are entrusted.”

Hugh Lee CEO and Founder

Careers

Working at KCRN Research!

We are promised to provide better working environment and you can expand your abilities! If you would like to become a part of our team, please send your CV to hr@kcrnresearch.com for new opportunities.

Contact Us...

Get in Touch with Us!

KCRN Research is located in Germantown, MD, conveniently placed near NIH and FDA national headquarters.

To request more information about KCRN or to inquire a service proposal, please email us at info@kcrnresearch.com or call us at 301-540-2600.

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ADDRESS

KCRN Research, Inc.

12311 Middlebrook Rd. Suite 200
Germantown, MD 20874
Tel) 301-540-2600
Fax) 877-310-9158
Email) info@kcrnresearch.com

© 2024 KCRN Research. All Rights Reserved.
12311 Middlebrook Rd. Suite 200, Germantown, MD 20874 | T.301-540-2600 | info@kcrnresearch.com