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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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