inSeption Group Adds Quality Assurance Expertise that Further Reduces Risk and Provides Cost Savings for Sponsors
Dawn Niccum is the new Director of Quality Assurance at inSeption Group, an organization changing the outsourcing paradigm by providing a unique approach and an alternative solution to clinical research outsourcing.
“I am honored to welcome Dawn to inSeption Group. Her extensive experience in clinical compliance, SOP development, computer system validation oversight, training, and safety will further strengthen our already highly experienced and passionate team,” said Joseph Arcangelo, Sr., Managing Partner of inSeption Group.
A member of DIA and SQA, Niccum’s career spans 20+ years in clinical trial and quality leadership roles in biopharmaceutical and pharmaceutical companies. She has a master’s degree in regulatory affairs and quality compliance, holds certifications as a Clinical Research Associate (CCRA), Registered Quality Assurance Professional – GCP (RQAP-GCP), and Project Manager (PMP), and is a registered nurse with experience working with the cardiac electrophysiology, bone marrow transplant, and cardiac and transplant surgical ICU departments.
As Director of Quality Assurance, Niccum oversees the growth and advancement of inSeption’s quality assurance group, assuming full autonomy and responsibility to meet the needs of both internal stakeholders and clients. She leads training in all aspects of quality assurance and administers inSeption’s comprehensive audit program, including the implementation of corrective and preventative action procedures.
“Her expertise in establishing quality structures and streamlined approaches to reducing risk will reinforce our commitment to operational innovation in the changing landscape of clinical quality and compliance,” Arcangelo added.
About inSeption Group
Driven by a vision to transform patient lives, inSeption Group is changing the outsourcing paradigm.
The company was founded by experienced industry professionals who had become fatigued with the traditional process for evaluating outsourcing vendors. In particular, the status quo involved too much variability regarding assessing a supplier’s resources, quality, time, and cost.
inSeption’s solution is a unique approach to clinical research outsourcing.
inSeption’s model attracts pharma leaders who are seeking a partner that has the passion and drive to conduct quality development and has exhaustive experience running full-service studies, strong relationships with site staff, and an expertise in the project-specific therapeutic area.
inSeption builds custom-designed, therapeutically-aligned functional teams with mutual goals that put the client at the helm, creating a level of program control and visibility no one else can offer.
For more information, visit http://www.inseptiongroup.com.
SOURCE: inSeption Group