inVentiv Clinical - Unique Clinical Solutions

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iCS Overview

Clinical Operations

Data Management & Biostatistics

Strategic Resource Groups

Contract Staffing

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From protocol design to regulatory submissions, inVentiv Clinical provides comprehensive and flexible clinical trial solutions. We can help you navigate regulatory, clinical, and research projects to achieve both short and long term objectives. Our best-in-class employee training programs ensure expert clinical, technical and medical professionals for every project.

So, whether you need full scale clinical trial management expertise or simply a team of monitors to manage your investigative sites, inVentiv Clinical can provide what you need, when you need it.

Clinical Operations Services

Trial Management
•	Protocol and CRF Design
•	Project management
•	Investigator recruitment
•	Patient recruitment and retention
•	Investigator meetings
•	Site monitoring
•	Safety monitoring
•	GCP audit support
•	eClinical solutions

Regulatory
•	Agency interaction/liason
•	Paper/electronic submissions for drugs/devices/biologics
•	DSMB participation
•	FDA Advisory Board presentation support

Medical Writing
•	Protocol preparation
•	Investigator brochure preparation
•	Integrated clinical study reports
•	Clinical abstracts and manscript prepartion
•	Regulatory document filing
•	Marketing and Regulatory documents
•	Editing and bibliography support
•	Scientific posters and papers
•	Technical documentation
•	Patient safety narratives
•	Electronic document prepartion

Regulatory Consulting/Liaison

inVentiv Clinical is experienced in virtually every aspect of the regulatory process, from developing preclinical strategies through final submissions. Before forming the blueprint for a product's regulatory program, we thoroughly assess existing product literature and the competitive and regulatory environment to define the most accelerated approach to obtaining registration.

Regional Monitoring Network

inVentiv Clinical has built a regional monitoring network that spans all major therapeutic areas. In addition to our existing monitoring team, we have unique access to an additional bolus of experienced monitors. We mandate rigorous in-house training for all monitors before beginning work on any project. Monitors then receive additional project-specific training at the beginning of each new client project. You can be assured that the regional monitors working on your project are the industry�s best.

inTelligent Site Selection & Patient Recruitment

With more and more clinical trials being conducted in the US every year, finding the right patients is becoming increasingly difficult. At inVentiv Clinical, we combine our operational expertise with the unmatched technological capabilities of our sister company, Adheris, to quickly and inTelligently find the right investigational sites and patients for your study. We utilize Adheris' proprietary database to profile potential investigators for your study and target appropriate patient populations for recruitment. We can then help to accelerate patient enrollment by working with both the physician and pharmacist to notify potential patients of your study.

Click here to download our Clinical Operations brochure in Adobe pdf.

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