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

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Company History

For the past 14 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.

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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.

Pre-IND Projects: Buerger’s Disease, Traumatic Brain Injury, Bechet's Disease, Hunter Syndrome, Duchenne Muscular Dystrophy, Anthrax
Updated as of April 1, 2025

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News & Events

What's new

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