Diverse Lynx : The Solution Provider - Deliverables

Careers

	Clinical Trials & Data Management Services
		Clinical Trial Services
		Data Management Services
		Offshore Services
		Therapeutics Areas
		Deliverables
		Management
		Advisors
		Contact

Clinical Data
Management
Services

Bio-Statistical
Service

SAS
Programming

Medical Writing

e-CRF and Paper CRF Design and Production	Clinical Trial Design	SAS Datasets Creation	Generate Clinical Study Reports and Documentation
Database Design	Sample Size Calculations	Data Listings, Tables, and Graphs	Protocol writing
Data Entry	Statistical Input to Protocols	Program Documentation	Interim and Final clinical study reports
Query Management	Interim Analysis	Program Validation	Investigator’s brochures
Medical Coding	Statistical Analysis Planning and Interpretation	Version Control and Archiving	Integrated summaries of efficacy and safety
Laboratory Data Administration And Radiology Images	Statistical Reports	Electronic (e-NDA) Submissions	Manuscripts for publication
Edit Checks and Data Validation QA audits	Generate Top Line results	Integrated Summaries of Safety and Efficacy	Abstracts for National and International meetings
Remote Data Capture
CRF Log and Tracking
Patients screening log
CRF Review
Double Data Entry and Verification
AEs/SAEs Reporting, Submissions and tracking

21 CFR Part 11 Compliance

	Computer access controls: Multi-layered Password, session timeouts, etc.

	Audit trails and other login securities
	Date/Time Stamps
	Systems Used for direct data entry and EDC
	System dependability tested continuously
	Ongoing training of personnel
	Copies of records and record inspection maintained securely
	Certification of electronic signatures

Our Commitments to the Sponsors:

Diverse Lynx standard commitments to its customers/sponsors:

	Importance of project management team - Diverse Lynx has core competency in the project management areas. Our high industry standard for the quality/education/training of clinical professionals provides advanced tools to maintain the efficiencies that bring to manage our customers’ clinical trial projects.
	Building cooperative relationship with sponsors - We continuously assess and provide improvement within the project-team responsible for clinical studies.
	Senior management oversees the projects - Diverse Lynx provides senior managers at Corporate level who are accessible to address any issues that may arise during the trial and provide valuable strategic guidance.


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