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.
- 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
- Medical writing
- 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
- Write charters
- Identification of medical readers and reviewers
- Image data management
- 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
- 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
- Life Cycle and Brand Enhancement