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 clinical trials 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

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Company History

For the past 6 years

From the beginning, we had the Sponsor’s mindset at our focus. The Founder of KCRN, before starting the company in early 2012, had an extensive experience on the Sponsor side of the industry, namely, as a clinical and regulatory project manager in pharmaceutical companies. As the primary contact for the CROs involved in his projects, he gained insight on the limitations of the Sponsor-CRO relationship. He often wondered why quality and a cost-effective budget cannot go together to provide a satisfying overall experience for everyone involved. Why do CROs sidestep from the partnership during project delay and readily take advantage of any opportunities that might increase the budget? These are the questions he set out to answer.

It was decided that with the right intent of the CRO, in taking true partnership with the sponsor company, to provide quality as well as cost-effectiveness, those issues could be resolved and the limitations of the Sponsor-CRO relationship could be improved. Today, we still operate with the same mindset. We have the interests of the sponsor in mind in every step of our operations. Because we have been there, and done that.

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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
Alzheimer’s Disease ✓✓ ✓✓ ✓*
Parkinson’s Disease ✓*
Spinal Cord Injury ✓*
Major Depressive Disorder
Type 2 Diabetics
Diabetic Macular Edema ✓*
Diabetic Retinopathy ✓*
Diabetic Neuropathy
Osteoarthritis ✓*
Post-operative Pain
Ulcerative Colitis ✓*
Tuberculosis ✓*
Atopic Dermatitis ✓✓ ✓✓
Erectile Dysfunction
Hepatitis C
Hypertension ✓✓ ✓✓
Bronchopulmonary Dysplasia
Bioequivalence & Medical Device ✓✓

Pre-IND Projects: Buerger’s Disease, Age-related Macular Degeneration, Traumatic Brain Injury, Bechet's Disease, Hunter Syndrome, Duchenne Muscular Dystrophy, Anthrax
Non-US Clinical Trials: Cerebral palsy *

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News & Events

What's new
(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.

News & Events List

Date Subject Contents
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 service in the complex and demanding world of pharmaceuticals, how can we accommodate both quality and efficiency? We have been looking for a solution. And we have found that this is an undertaking that requires being able 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

We are focused on doing what a CRO is made to do, and doing it well. The way we operate reflects our main objective: successfully carrying out and completing each project, with Sponsor-centered mindset. We try to share the same mindset as that of the Sponsor and therefore want to ensure that our operations are executed with maximized efficiency and quality. In ensuring that efficiency is maximized, 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 to quality. One of the ways in which we accomplish this is by finding the most suitable person for each area of specialty required for each specific project. Whether it is one of our team members or an external expert, you can be confident that your project is being done well in good hands.

Fixed cost & Incentive system

We take responsibility for our work. Literally. We strive to share the mind of our clients during both good times and bad times by offering fixed costs for our services. In other words, KCRN Research is willing to take part in being a team, even in unexpected and unfavorable situations such as project delay or other undesired results. And of course, when things go as planned and we are able to provide you with good results, you will be satisfied and we will be, too – a true win-win situation. For whatever situation, we aim to keep our word. 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 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.

Every project is different, but regardless of the differences, we strive to facilitate the Sponsor-CRO relationship with the following:

Open communication

We facilitate effective external and internal communication to ensure that 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 and turns in the course of the project. We are fast to shift, adjust, and advance so that we are consistently focused and 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 are providing 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.

The 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 are offering the following customized services to clients according to their various needs

To pharmaceutical/biotech companies:

  • Sponsor Project Manager
  • Sponsor CRA

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 Project Manager and Founder

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, LLC.

20251 Century Blvd. Suite 325
Germantown, MD 20874
Tel) 301-540-2600
Fax) 877-310-9158