KCRN Research

05/23/2025

KCRN Research and QuBEST BIO at their booths today at the Korean Society of Nonclinical Study 47th Spring Workshop in Gyeonggi-do Province in South Korea.

It was a wonderful time and met many great people at the event while speaking to interested parties on how to effectively coordinate their drug development plans into US clinical trials and US regulatory affairs.

Come to kcrnresearch.com to see how we can help your drug development plans get to the next level.

#임상연구 #규제업무

05/14/2025

US Clinical Research & Regulatory Affairs CRO KCRN Research and Nonclinical CRO QuBEST BIO just wrapped up with a successful joint seminar last week in South Korea!

KCRN Research founder and CEO Hugh Lee made a presentation titled "US FDA 임상 1상 승인을 위한 전략적 접근" to those interested in drug development in the US in the current industry landscape.

"US FDA 임상 1상 승인을 위한 전략적 접근"
FDA IND 의 이해
글로벌 신약개발 시 미국에서의 임상 1상을 위한 고려사항

Hugh Lee will remain in South Korea will be remaining in South Korea for a little while before returning to the US.

If you are interested in meeting with Hugh and KCRN Research about Drug Development in the US or Regulatory Affairs in the US, please contact us at josephhong@kcrnresearch.com so that we may happily set up an available time to meet and discuss you and your organization's plans.

Both Korean and English speakers are all welcome!

Let us show you the difference KCRN Research can make to help you with your drug development goals!

#신약개발 #규제업무 #미국신약개발 #미국규제업무

12/10/2024

ELEVAI BIOSCIENCES, part of the Elevai Labs and Elevai Skincare family, and KCRN Research, a Korean-American Clinical and Regulatory Affairs CRO based in Germantown, MD, are now moving to file an Investigational New Drug (IND) application for novel next-gen obesity treatment EL-22 and are set to prepare fpr pre-IND meetings with the US FDA.

Phase1 clinical trial data has shown that while EL-22, an oral GLP-1 therapy, is just as effective as many other GLP-1 therapies when it comes to weight loss, it has also shown increases and growth towards the body's muscle cells. Something that is a serious drawback to many GLP-1 weight loss treatments.

If a new IND application is granted by the US FDA, Elevai Biosciences and KCRN Research plan to move forward with Phase 2 of Clinical Trials in order to further test the treatment's ability and promise to helping obese patients lose much needed weight while also preserving lean muscle mass.

For more information about Elevai Biosciences and EL-22, please visit their website at elevaibio.com.

Press Release - 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

#글로벌임상 hashtag hashtag #임상 hashtag #신약개발 hashtag

10/23/2024

KCRN Research CEO Hugh (Hyungjoo) Lee gave a special lecture on the "Practical Aspects for US RA and Clinical Trials in Early Phase Development" at the 2024 Fall International Convention of The Pharmaceutical Society of Korea in Seoul, South Korea. - October 23, 2024.

https://www.psk.or.kr/
https://conference.psk.or.kr/

#글로벌임상 #임상 #신약개발

10/22/2024

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

#글로벌임상 #임상 #신약개발

10/17/2024

We are here at the KSNS Autumn Workshop and open to meeting with you tomorrow here in Gyeongju, South Korea and will be available after as well if you wish to have a 1:1 consultation on preclinical and nonclinical services (QuBEST BIO) or US regulatory affairs and early phase clinical trials.

Please contact us at josephhong@kcrnresearch.com or info@qubest.co.kr if you would like to know more.

hashtag #글로벌임상 hashtag hashtag #임상 hashtag #신약개발 hashtag

09/30/2024

Come and Join KCRN Research in a 1:1 Meeting in South Korea this October!

We will gladly answer any and all questions that you may have with regards to the US Drug Development industry, questions on the US FDA and other Regulatory Affairs topics, and Clinical Trials in the US. Let us help you get your development pipeline on track.

We will be in South Korea this month during the 2024 KoreaBio Convention on October 10 ~ 11 and the KSNS 46th Autumn Workshop on October 17 ~ 18.

Please sign up for one of our Meeting Blocks at kcrnresearch.com/meet.

We hope to see you there!

KoreaBio
https://www.koreabio.org/

KSNS
https://www.nonclinical.org/

#글로벌임상 #임상 #신약개발

04/25/2024

There are still a few registration spots open if you are interested in joining us with discussions about the US FDA and US Regulatory Affairs work in Drug Development.

Please Register Here:
https://www.kcrnresearch.com/meet

큐베스트바이오는 미국 자회사 KCRN Research와 12년 이상 개발후보물질 선정을 위한 비임상 후보물질 최적화 시험 (약효/PK/예비독성), 글로벌 인허가기관 자료제출이 가능한 개발후보물질의 GLP 독성시험 계획수립, 수행 및 자문, US FDA RA 업무 및 미국 초기 임상시험 CRO 서비스 등 신약 R&D 과정의 초기 단계 성패를 좌우하는 “Sweet Spot”에 해당하는 시험서비스와 자문/PM을 제공하여 왔습니다.

또한, 국가신약개발사업단(KDDF)의 “Global RA 지원과제” 주관기관으로 KDDF 과제에 대해 US FDA RA 지원 업무를 성공적으로 수행하고 있습니다.

많은 회원사에서 글로벌 신약개발과정 중 US FDA RA 업무와 초기 임상시험을 계획하면서 여러 어려움을 겪게 되는데 본 행사를 통해 현장에서의 경험과 지식을 바탕으로 한 자문을 받아 보시기 바랍니다.

Date: 2024년 4월 29일 (월) 및 4월 30일 (화), 오전 9시 ~ 오후 6시

Place: 한국바이오협회 회의실
* 경기도 성남시 분당구 대왕판교로 700 코리아바이오파크 C동 1층

Price: 무료

Q&A Portion Length: 40~50분/회사 배정
- KCRN Research 소개 (10분), Q&A (30분)
- 신청과 동시에 Question 제출해 주실 경우 준비에 도움이 되겠습니다.

Participants:
- KCRN Research: 이형주 대표
- 큐베스트바이오: 김수헌 대표

Inquiry Email: hughlee@kcrnresearch.com

Send Request for Meeting: https://www.kcrnresearch.com/meet

#글로벌임상 #임상 #신약개발

04/09/2024

US FDA and US Clinical Trials CRO KCRN Research CEO Hugh Lee will be in Korea starting on 23 April 2024 for five weeks afterwards until near the end of May.

If you are in South Korea and would like to discuss with him about your US FDA Regulatory Affairs or IND plans or about conducting Clinical Trials in the United States, please reach out to us at:

hughlee@kcrnresearch.com or
info@kcrnresearch.com

and we can arrange a meeting for conversation. You may reach out to us at any time before he leaves back to the US near the end of May.

Hugh Lee will also be presenting at a Client Q&A Day between 29 April - 30 April 2024 at the Bio Korea Association in Seongnam-시, Gyeonggi-do.

If you would like to participate, please register at https://www.kcrnresearch.com/meet before the deadline of 23 April, 2024.

QuBEST BIO & KCRN Client Q&A Session Information -

Date: 2024년 4월 29일 (월) 및 4월 30일 (화), 오전 9시 ~ 오후 6시

Place: 한국바이오협회 회의실
* 경기도 성남시 분당구 대왕판교로 700 코리아바이오파크 C동 1층

Price: 무료

Q&A Portion Length: 40~50분/회사 배정
- KCRN Research 소개 (10분), Q&A (30분)
- 신청과 동시에 Question 제출해 주실 경우 준비에 도움이 되겠습니다.

Participants:
- KCRN Research: 이형주 대표
- 큐베스트바이오: 김수헌 대표

Inquiry Email: hughlee@kcrnresearch.com

Send Request for Meeting: https://www.kcrnresearch.com/meet

Application Deadline: 2024년 4월 24일(수)까지
* 신청자가 많은 경우, 조기 마감될 수 있음

#글로벌임상 #임상 #신약개발

04/09/2024

QuBEST BIO and KCRN Research will be holding a Client Q&A Day on April 29 - April 30, 2024 in Seongnam, South Korea. Come and join us as we answer all of your questions about US Regulatory Affairs and US Early Clinical Trial Services.

Please Register Here: https://www.kcrnresearch.com/meet
Deadline to register is April 24, 2024

큐베스트바이오는 미국 자회사 KCRN Research와 12년 이상 개발후보물질 선정을 위한 비임상 후보물질 최적화 시험 (약효/PK/예비독성), 글로벌 인허가기관 자료제출이 가능한 개발후보물질의 GLP 독성시험 계획수립, 수행 및 자문, US FDA RA 업무 및 미국 초기 임상시험 CRO 서비스 등 신약 R&D 과정의 초기 단계 성패를 좌우하는 “Sweet Spot”에 해당하는 시험서비스와 자문/PM을 제공하여 왔습니다.

또한, 국가신약개발사업단(KDDF)의 “Global RA 지원과제” 주관기관으로 KDDF 과제에 대해 US FDA RA 지원 업무를 성공적으로 수행하고 있습니다.

많은 회원사에서 글로벌 신약개발과정 중 US FDA RA 업무와 초기 임상시험을 계획하면서 여러 어려움을 겪게 되는데 본 행사를 통해 현장에서의 경험과 지식을 바탕으로 한 자문을 받아 보시기 바랍니다.

Date: 2024년 4월 29일 (월) 및 4월 30일 (화), 오전 9시 ~ 오후 6시

Place: 한국바이오협회 회의실
* 경기도 성남시 분당구 대왕판교로 700 코리아바이오파크 C동 1층

Price: 무료

Q&A Portion Length: 40~50분/회사 배정
- KCRN Research 소개 (10분), Q&A (30분)
- 신청과 동시에 Question 제출해 주실 경우 준비에 도움이 되겠습니다.

Participants:
- KCRN Research: 이형주 대표
- 큐베스트바이오: 김수헌 대표

Inquiry Email: hughlee@kcrnresearch.com

Send Request for Meeting: https://www.kcrnresearch.com/meet

Application Deadline: 2024년 4월 24일(수)까지
* 신청자가 많은 경우, 조기 마감될 수 있음

#글로벌임상 #임상 #신약개발

03/07/2024

Let KCRN Research be your REGULATORY guide to the US FDA for your drug development needs.

KCRN Research specializes in working with Korean Drug Development companies like yours and helps them through the process of regulatory meetings, filings, and analysis with the US FDA.

Our regulatory team of Korean-speaking members works around the clock to help make sure that your drug development products get the support that they need and deserve.

Our regulatory services include but not limited to:

*Gap Analysis
*Pre-IND meeting
*Scientific Advisory Board (SAB) Formation
*Protocol development
*IND filing and follow-up (CTD / eCTD)
*Orphan Drug Designation (ODD)
*Fast Track Designation
*Other FDA correspondences (Safety reporting, etc.)

Contact us at info@kcrnresearch.com and learn how KCRN Research can help support you.

Early Phase Clinical Trials

02/16/2024

Working on a new drug development product or services? Why not let KCRN Research help you bring that to America?

We specialize in providing Korean life science companies like yours with experienced US clinical research and regulatory services for their drug development ideas.

Expand your horizons with KCRN Research.

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

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.)

Early Phase Clinical Trials