Services – KARYOON CONSULTING SERVICES

End-to-End Clinical Trial Solutions

At Karyoon Consulting Services, we help biotech startups, researchers, and sponsors bring their innovations to life. From early research to post-market studies, we provide smart, cost-effective solutions that simplify clinical trials and speed up your path to success.

With deep expertise in regulatory compliance, trial operations, and global strategy, we take care of the details, so you can stay focused on the science.

Our Services

Preclinical & Early Stage Support

Build a strong foundation for your first human trial

Develop preclinical study protocols aligned with future clinical objectives
SOP Development for GLP/GMP compliance
QMS Implementation
Gap analysis and package preparation for first-in-human trials

Ethics & Compliance

Ensure your study meets ethical and institutional standards

HREC applications & ethics submissions
Investigator Brochures (IBs)
Informed Consent Forms (ICFs)
Safety monitoring plans: DSURs/PSURs

Regulatory & Governance

Navigate global and local regulatory requirements with confidence

TGA CTN/CTA submissions
Trial registrations: ANZCTR, ClinicalTrials.gov
Vietnamese MOH submissions and import licences

Clinical Trial Management

Comprehensive support for every clinical trial phase (1 to 4)

Site selection & activation
Vendor and financial oversight
Data analysis, closeout, and archiving
Clinical evidence packages for submissions

Quality Assurance & Documentation

Maintain compliance and data integrity throughout your clinical trial

Trial Master File (TMF) setup and management: eTMF or paper
SOP development & CAPA systems
Data integrity audits

Medical Writing & Other Services

Clear, compliant documentation to support your clinical trial

Medical writing: protocols, reports, safety documents
Project management
Vietnamese/Chinese translation for global trials