Clinical Development

  • Services
  • Clinical Development
Regulatory Affairs Medical Writing Clinical Operations Project Management Data Management Biostatistics
01

REGULATORY AFFAIRS

Based on extensive experience and know-how in various clinical trials and regulatory affairs of our Regulatory Affairs team, we provide one-stop service for all healthcare areas including pharmaceutical products, medical devices, and health functional foods from development stage to product approval. Our RA team gives clients the best strategy to get their product to market faster and more efficiently.
Our Services :

Pharmaceutical Product Approval

  1. 1.Pharmaceuticals / Biologicals / Cell therapy / Herbal medicines
  2. 2.NCE (New chemical entity) / IMD (Incrementally modified drug) / Generic
  3. 3.IND / NDA / BLA application
  4. 4.Common Technical Documentation (CTD)
  5. 5.Safety & Efficacy review / S&TM (Specification & Test Method) review / GMP data review
  6. 6.CMC Consulting
  7. 7.Pharmacovigilance / RMP
  8. 8.DMF (Drug Master File)

Medical Device Approval

  1. 1.Support for medical device clinical trial plan approval (IDE, Investigational Device Exemption)
  2. 2.Medical device product approval (Manufacturing/Importing)
  3. 3.Technical documentation review/documentation
  4. 4.Safety & Efficacy data review/documentation

Health Functional Food Approval

  1. 1.Individual certification for functional ingredients
  2. 2.Notification of the manufacturing product
02

MEDICAL WRITING

Our Medical Writing team is a team of expertise in a wide range of therapeutic areas and all phases of clinical trial with the scientific background to produce structured and accurate documents fully compliant with GCP guideline and other regulatory requirements currently in force.
Our Services :
  • Study document development and review (IB, protocol, CRF, ICF, publications, abstracts)
  • Preparation of submission packages in collaboration with Regulatory Affairs Team
  • Literature summaries of safety/efficacy
  • Support for preliminary meetings with Regulatory Authorities
  • Develop and review Risk Management Plan
  • Investigator Meeting
03

CLINICAL OPERATIONS

Our Clinical Operation team provides the quality and accuracy of each study with adherence to applicable regulations, protocol and SOPs. Our clients are provided with project teams of experienced clinical research professionals where each study will be led to ensure a successful site start-up through Pre-Study Visit (PSV) and Study Initiation Visit (SIV), maintenance through Study Monitoring Visit (SMV) and completion through Study Close-Out Visit (SCOV).
Our Services :
  • Site Feasibility Study/Pre-Study Visit
  • Study Initiation Visit
  • Study Monitoring Visit
  • Site Management
  • Study Close-Out Visit
  • Source Document Review
  • Regulatory Document Review
  • Investigational Product Accountability
  • Report Generation
04

PROJECT MANAGEMENT

Project management is a critical part of a trial’s success and all of the clinical trials conducted by Dt&SanoMedics are led and managed by Project Managers. Our experienced Project Managers operate and manage efficiently at all stages, from study design until the conduct of the study is complete, in terms of high standard guide of your studies in all quality, resources, timelines and budget.
Our Services :
  • Project planning and management
  • Primary point of communication for clients and project team
  • Budget Management
  • Investigator Meeting
  • Issue Management
05

DATA MANAGEMENT

Our Data Management team provides comprehensive clinical data management services, from trial Case Report Form (CRF) design to database lock. Our experienced team work in compliance with ICH guidelines, 21 CFR part 11 and KGCP to provide the most appropriate and qualitative solution to meet clients’ clinical development needs.
Our Services :
  • Data Management Plan (DMP) writing and maintenance
  • Data Validation Plan (DVP) establishment
  • Design & Development of Case Report Form (CRF) / e-CRF & annotation
  • Electronic Data Capture (EDC) applications setup across major EDC
    platforms & EDC data management
  • Medical Terminology Coding using MedDRA, WHOART, WHODD
  • Reconciliation of Adverse Events and Serious Adverse Events
  • External Data Management
  • Database Quality Check
  • Database Lock
  • Study Data Transfer
  • Full EDC integration & CDISC compliance
  • Complete validated systems & environment (21 CRF Part 11, ICH compliance)
  • CDISC SDTM database conversion programming
06

BIOSTATISTICS

Our Biostatistician team provides a comprehensive and customized service in accordance with current ICH Guidelines E3, E6, E9, E10 and other regulatory requirements.
Our Services :
  • Consulting on clinical trial design and protocols, including statistical epidemiology and adaptive design studies
  • Collaboration with medical team to ensure the consistency and quality of deliverables
  • Sample size / Power Calculations
  • Randomization services (IVRS/IWRS)
  • Designing Statistical Analysis Plans (SAP)
  • Full service or independent biostatistical and programming support
  • Preparing Statistical Reports – Interim, Final and Clinical Study Reports, DSMB
  • Provision of CDISC: ADaM compliant analysis datasets