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Diverse Lynx 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 Development Plan
Global (EU, USA, Japan, India)
Clinical Studies
Develop CDP and Protocol
Phase I, II, III, IIIb and IV
Observational and Registry studies
Regulatory Submission
Patient Recruitment
Monitoring
Trial Management
Imaging
Phase I QTc Trials
IVRS
CTM Storage & Distribution
Data Management
Medical writing
CDP & Timeline
Imaging Capability
Imaging:
Write charters
Identification of medical readers and reviewers
Site training
Image transfer from overseas
Unreadable images and interpretation
Central reading
Image data management
Regulatory Affairs Capability
Regulatory
Pre-IND meetings, IND preparation
End of phase 2 FDA meetings
On going protocol related questions and answers
Investigator Drug Brochures
Regulatory Submissions
FDA
EU Commission, European countries
MHLW, Japan
DCGI, India
Support IND & NDA submission
Medical Capability
Product Development
Phase IIIb
NDA submission
Life Cycle Management
Post-Marketing Clinical Trials and trial design
Market feasibility analysis
Investigator Sponsored Trials
Cooperative Group Trials
Company Sponsored Trials
Observational trials and Registries
Phase IV trial; long-term survival, long-term safety, end stage pain
KoLs support for publication and additional study design
Operations Capability
Project Management
Country selection
Chief Investigator selection
Investigators selection
Contract and budget
Clinical trial management
Medical monitoring
CTM Supply
Timeline
Patients recruitment
Data management
Imaging data management
Central laboratory data management
Safety data management
CSR
Life Cycle and Brand Enhancement
Line extensions
New dosage forms strength
Packaging
Replacement switches
In-license
Isomers/metabolites
Use
Combinations
Dosing schedule
New Indications
Regulatory
Pediatric exclusivity
Orphan drug
Patent term restoration
Labeling
Regulatory guidance
KOLs
EU, USA, Japan, Asia
Marketing
Publications
MedOnc/RedOnc
Community and Academic
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