Novella Clinical

Corporate Description

Novella Clinical, a Quintiles company, is a full-service clinical research organization headquartered in Research Triangle Park, N.C.. Founded in 1998, Novella specializes in serving the unique needs of small and mid-sized oncology companies, and medical device companies of all sizes. Novella integrates deep clinical and therapeutic expertise, operational excellence, and a superior level of customer service to streamline product development.

Contact Information

Scotlan Liles
Marketing Coordinator
Novella Clinical
1700 Perimeter Park Drive
Morrisville, NC 27560
USA
919-484-1921
919-313-1495 (fax)
info@novellaclinical.com
www.novellaclinical.com/
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Markets Served

Novella specializes in serving two distinct markets: small and mid-sized biopharma companies, and medical device companies.

Biopharma Oncology

Novella excels in working with smaller biopharma companies with a strong emphasis on oncology. Oncology clinical trials are inherently complex and require experienced teams across all clinical research disciplines. Supporting sponsors in Phase Ib through post-approval, we deliver specialized teams, preferred site relationships, board-certified hematologists/oncologists and global feasibility.

Medical Device and Diagnostics

Conducting pilot, pivotal and post-approval studies, Novella’s Medical Device & Diagnostics Division has earned preferred vendor status with multiple leading medical device companies.

Experienced across trial types, we offer services from regulatory consulting through the development process.

Major Services

Novella offers both full-service capabilities, as well as flexible capabilities. Our expertise includes:

  • Program Management
  • Investigator Site Strategy & Coordination
  • Clinical Monitoring
  • Data Management
  • Biostatistics
  • Medical Monitoring
  • Safety Management
  • Regulatory Consulting
  • Clinical Endpoint Committee Management
  • Data Safety and Monitoring Board Management
  • Clinical Advisory Board Management
  • Medical Writing
  • EDC Programming & Hosting
  • eCRF Design & Programming
  • eClinical Investigator & Staff Training

Novella Clinical Resourcing

For our customers who may not require a full-service outsourcing option, our resourcing division, Novella Clinical Resourcing, offers an attractive alternative. With extensive expertise in both clinical resourcing and clinical operations, we provide insourcing and outsourcing services, from flexible staffing solutions to customized Functional Service Provider (FSP) programs.

Commitment to Quality

Novella Clinical's quality management processes are integral to all aspects of our business. Our independent Quality Assurance department performs regular quality assessments of our services to ensure compliance with FDA (21 CFR 312) and international GCP regulations, ICH, ISO, our SOPs and our commitment to customers.

Novella's commitment to quality facilitated our North American headquarters to earn ISO 9001:2008 certification in 2004 and recertification in 2010 and 2013. Today each Novella location operates under our centralized quality management system.

Contact Information

Scotlan Liles
Marketing Coordinator
Novella Clinical
1700 Perimeter Park Drive
Morrisville, NC 27560
USA
919-484-1921
919-313-1495 (fax)
info@novellaclinical.com
www.novellaclinical.com/
View Map

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