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Clinical Trails

I28Tech is adept at creating aggregate reports per regulatory agency guideline for aggregate report writing of EU RMP/RiskMAPs/REMS/PIPs, SUSAR, PSUR, PADER, ASR, DSUR, SBR and other aggregate reports. At I28Tech has experienced clinical/medical writers with specific therapeutic areas with relevant medical degrees who are experts in medical assessment, risk assessment and interpretation with clinical/medical judgment. I28Tech Clinical Trial Services provides comprehensive early Phase 1, Biomarker, bioequivalence evaluations, Phase 1 to Phase IV Clinical Studies and Bio-Analytical assay. We support our customers with a 100% success rate in completing their clinical trials within a pre-defined timeline. Together with our offshore team, we have more than 400 full time staff which we augment when needed. Our fully scalable solution provides.

 

CRO Services

 

  • Clinical Operations: A comprehensive and full service operations to support Pre-IND, IND, NDA and beyond the NDA for our customers.
  • Data Management & Biostatistics: User-friendly integration of data management tool with highly skilled statistical and medical writing expertise.
  • Clinical: Manage clinical professionals; Medical Monitor, Medical Officer Safety, Project Manager, Clinical Research Associate, Medical Writer. High quality and cost effective on-shore and off-shore talents to meet our clinical trial needs.
  • Clinical investigators: Provide highly experienced investigators, trained clinical research associates and nursing staff with extensive experience in relevant therapeutic areas.

 

Research and Development

 

  • Global Clinical Development Plan
  • Phase I QTc Trials (PK/PD of Cardiac Repolarization) in Healthy subjects
  • Phase I QTc Trials (PK/PD of Cardiac Repolarization) in cancer patients
  • Phase I, II, III
  • Patient Recruitment
  • Clinical Monitoring
  • Medical Monitoring
  • Trial Management
  • Data Management
  • Biostatistics
  • Medical writing

 

Product Development

 

  • Post-Marketing Clinical Trials and trial design
  • Phase IIIb and IV
  • Life Cycle Management
  • Market feasibility analysis
  • Investigator Sponsored Trials
  • Cooperative Group Trials
  • Observational trials and Registries
  • KoLs support for publication and additional study design

 

Imaging

 

  • Write charters
  • Identification of medical readers and reviewers
  • Image data management

 

Regulatory Affairs

 

  • Pre-IND meetings, IND preparation
  • End of phase 2 FDA meetings
  • Investigator Drug Brochures
  • FDA intercation
  • EU Commission, European countries
  • MHLW, Japan
  • DCGI, India
  • Support IND & NDA submission

 

Project Management

 

  • Country selection
  • Chief Investigator selection
  • Investigators selection
  • Contract and budget
  • Clinical trial management
  • Medical monitoring
  • Patients recruitment
  • Data management
  • Imaging data management
  • Central laboratory data management
  • Safety data management
  • CSR
  • Life Cycle and Brand Enhancement

 

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