Niche Service Providers Initiate New Clinical Trial Outsourcing Model

–  In order to provide a world-class outsourcing solution for the pharmaceutical, biotech, and medical device industries, that is cost-effective and operationally efficient, a consortium of clinical trial management experts has been formed.  

“There has been a significant shift within our outsourcing industry.  We have seemingly lost sight of the responsibility we once had to our clients and investigative sites, a centricity that helped build and shape our industry over the past three decades,” says Joe Arcangelo of the inSeption Group. 

“This change has created an inconsistency in operational delivery and has helped drive many of the best and brightest people out of the “mainstream” of Pharma/CRO employment.  What we have seen is a tremendous influx of these high quality experts entering into independent consulting, creating niche companies with functional or therapeutic expertise, or making the choice to join smaller development companies,” said Arcangelo.

“So, why not put these individual entities together providing clients a seamless, integrated, highly expert group of people who share personal attributes of excellence?” questions Arcangelo.  

With a commitment to positively change the industry, a group of companies have formed an alliance bound by common threads of passion, integrity, drive, and service.  Companies that comprise this consortium to date include Clincierge, FMD K&L, InSeption Group, LLC, OneSource Regulatory, LLC, and Pyxa Solutions, LLC with room to grow. 

The goal of this alliance is to leverage the strengths of each member organization delivering equilateral expertise across all functional areas that comprise the R&D organization.  In doing so, the consortium is planning on mitigating client risk, driving efficiency and improving timelines, removing barriers that prevent getting treatments to market in a timely fashion; thereby, improving patient outcomes.    

In working with the member organizations, clients will be provided one point of contact.  This individual will ensure that there is a seamless integration with the member companies by overseeing all aspects of the project to provide transparency and ensure all overlaps are managed appropriately.

If you’re ready to learn more about how the consortium can help you become more efficient and cost-effective in executing your clinical trials, we invite you to contact us by emailing jarcangelo@inseptiongroup.com. 

About the Consortium Companies

Clincierge®

Clincierge® reduces barriers to clinical trial participation, enhancing enrollment, and reducing drop-outs by putting

patient needs first. They provide personalized support, travel and accommodation logistics, and directly pay trial-related costs outside of reimbursable incidental expenses.

To learn more, visit www.clincierge.com.

FMD K&L

FMD K&L is a Contract Research Organization (CRO) offering data management, biostatistics, statistical programming, CDISC-compliant eSubmission, drug safety, and medical writing services to pharmaceutical, biotechnology, and medical device industries worldwide.  Additionally, we offer regulatory affairs in China and South East Asia, and clinical operations in mainland China, Hong Kong, Taiwan, South Korea, and Europe. 

To learn more, visit www.klserv.com.

inSeption Group

inSeption Group was founded by experienced industry professionals to create alternative solutions to traditional outsourcing options.  inSeption has the unique ability to attract and bring together the most skilled and experienced personnel from across the industry, and create, in active collaboration with our clients, custom-designed, hand-selected, therapeutically-aligned teams devoted to delivering clinical and operational expert solutions. 

To learn more, visit www.inseptiongroup.com.

Pyxa Solutions

Founded in 2012, Pyxa specializes in global Regulatory services and solutions for the pharmaceutical industry by improving regulatory performance through analysis of your organization, recommendation and development of improvement plans, and implementation of robust solutions.

Pyxa provides solutions specializing in Submission Management, Information and Systems Management, Process Development and Optimization.

To learn more, visit www.pyxasolutions.com.   

OneSource Regulatory

OneSource has expert staffing solutions for your organization, selected and overseen by experts who have done the job. OneSource specializes in Regulatory and Medical Advertising & Promotion, Regulatory Drug Product Labeling, and Healthcare Compliance. OneSource co-founders and staff are experts in our core areas of service.

Unlike traditional consulting companies or staffing firms, our co-founders oversee the staff we place with your company – we have the ability and capabilities to do just that because we've done this work ourselves as industry senior leaders. At OneSource, our team is interested in ensuring compliance, while maximizing commercial effectiveness.

To learn more, visit http://onesource.launchrock.com/.