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KYM BioMedical Research

Doing Clinical Research the Right Way

We help our clients exceed their goals through closing the gaps between data, science and life-changing medicines.

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KYM Research Services

Exceeding Your Expectations on Time

KYM Research's services focus mainly on two core domains of the clinical trial operations, biostatistical support and integrated data management solutions, but complemented by (integrated) project management and regulatory affairs support, as needed.

Biostatistical support: Phase I-III Clinical Trials

  • General statistical consulting

  • Study Design and Protocol Development 

  • Endpoint and assessment determination

  • Sample size determination and power analysis simulation

  • Randomization schedule generation

  • Statistical analysis plan (SAP) development

  • Statistical analysis and interpretation and table, listing, and figure production

  • SAS programming for CDISC dataset

  • Data and safety monitoring

  • Clinical study report (CSR) input

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General Clinical Trial Conduct Services

  • Project Management

  • CRO selection and operation oversight

  • Medical Writing, Professional Medical Translation

  • Site Monitoring and Management

Regulatory Services

  • IND Filing and Material Preparation

  • Scientific Advisory Board (SAB) Formation and Consulting 

  • Pre-IND Meeting 

  • End of Phase I meeting and other Meeting with the FDA

  • Fast Track Designation 

  • Orphan Drug Designation (ODD) 

  • Other FDA Related Communications

About KYM BioMedical Research

KYM BioMedical Research (KYM Research) is a leading provider of statistical and project management consulting services for the Korean pharmaceutical, biotechnology and life-science companies wishing to enter the US market.  We provide the full spectrum of biostatistical services (from the statistical aspects of a study’s design through the statistical analyses and interpretation of the study results) and complete, integrated, project management services.  In addition, we can provide regulatory assistance related to your Investigational New Drug (IND) application support for your clinical trials.

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We are located close to the Research Triangle Park (RTP), the largest research park in the United States and a major hub of life science and drug development.  Since being established in 2009, KYM Research has had broad experience in various therapeutic areas and trials conducted under FDA IND and Investigational Device Exemption (IDE) applications.  We have experience working with small, mid-size, and large sponsors, in all phases of development, and across various indications.  We specialize in providing services for multicenter phase I through III trials.

 

For more information about the services we provide, reach out today.

Integrated Trial Management solutions

  • CRF Development

  • Data Management Plan and Manual of Procedures

  • Data Quality Assurance

  • Information System (CTMS/EDC) Development and Validation

  • Customized functionalities, including Regulation Management, Risk-based Monitoring, Adaptive Randomization, Study Drug Tracking, Medical Adjudication

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KYM Research Projects/ Experience

Our Capabilities to meet Your Expectation on Time and on Budget

In this industry, every second counts and the on-time delivery is critical. We commit to meet your expectations both on time and budget, while providing the top quality services.  We will work tirelessly with you to keep your clinical studies moving forward as rapidly as possible.  Further, with the support of our sophisticated Clinical Trial Management System, our team will provide real-time study updates and study milestones to help you make time-sensitive decisions.

KYM Research enjoys the rich research environment of the Research Triangle Park (RTP), which is one of the fastest growing life science research hubs in the United States.

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RTP is named for the three major research universities (Duke University, North Carolina State University and University of North Carolina – Chapel Hill) in the area of three major cities (Raleigh, Durham and Chapel). RTP is the most prominent and largest research and development park for high-tech and life science companies in the United States. RTP has almost over 100 life science companies employing 25,000 workers and contributing $ 9.8 B to regional economy, including GlaxoSmithKline main R&D center, Merck, Novo Nordisk, Syngenta, Sandoz, Pfizer, IQVIA, RTI, PPD, Rho, Biogen, Ajinimoto, Novozymes, United Therapeutics, etc.

For more information, email us at info@kymresearch.com

Therapeutic Areas

  • Oncology

  • Neurology and Neurosciences

  • Cardiovascular/Metabolic

  • Central Nervous System

  • Endocrinology & Metabolic Disease

  • Psychiatry/Psychology

  • Pulmonary/Respiratory Diseases

  • Dermatology

  • Tele-Medicine

  • Medical Device

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