CTMG’s Chief Quality Systems Engineer / Director of Quality Systems receives Honors

Michelle Nanney, BSE, MS, MBA, who serves as CTMG, Inc.’s Chief Quality Systems Engineer / Director of Quality Systems, has recently received honors from two nationally recognized engineering societies. Ms. Nanney has been elected a Senior Member of IEEE (Institute of Electrical and Electronics Engineers). IEEE has over 421,000 members in over 160 countries. The […]

Independent Auditor Gives CTMG High Marks

CTMG recently had an independent audit performed for one of their clinical trials. The auditor stated that he found CTMG’s processes to be sound with no deficiencies. He remarked on CTMG’s state-of-the-art temperature monitoring system and praised the Quality Systems department for their EDC verification process. He also stated that he had never completed his […]

Professional Patients: A Problem for Clinical Trials

A recent Forbes article details the unseen world of individuals who pose as appropriate participants for multiple clinical studies to reap the rewards that stipends provide. Networking via social media has refined the process to include a ‘scout’ participant who relays study inclusion/exclusion criteria to the group to ensure that all who follow know just […]

Process control for key enrollment events – how any site can use a partner SSRO to ensure study completion timelines are met as intended

Subject enrollment into a clinical trial is one of the most important aspects that ensure the study will be completed within the timeframe intended. Although it seems like a straightforward and simple process, there are multiple inputs and process steps involved. Finding the right patients: For a busy clinical site – the kind that a […]

Busy Clinical Sites Need Support to Carry out Protocol Procedures as Intended – the SSRO Solution

Neither physicians nor other investigative site personnel are trained in process development and verification – skills that are evermore necessary as study protocols become more complex and seek to identify treatment effects that are more subtle or difficult to distinguish within already medicated patient populations. Because of this, disruptions that occur to patient progress in […]

CTMG attends FDLI premier Annual Conference 2015

UsalaFDLI2015

CTMG’s CEO, Anton-Lewis Usala, MD returned to Washington DC this week to present at the Food and Drug Law Institute’s premier Annual Conference, focused this year on Recent Trends in Data Integrity Compliance and Enforcement. Dr. Usala profiled the key strengths of the SSRO approach – Adaptive Investigative-Site Management (AIM) – in ensuring that high […]

CTMG President and CEO speaks at FDLI Conference

UsalaSpeaking500px

CTMG President and CEO, Anton-Lewis Usala, MD , was invited to speak at the Food and Drug Law Institute’s Enforcement, Litigation & Compliance Conference on December 9, 2014 in Washington, DC. Dr. Usala spoke on issues affecting “Clinical Trial Data Integrity—The Investigative Site”. The FDLI Enforcement, Litigation & Compliance Conference is held to examine the […]

Faster Enrollment. Better Data. Period™

After hearing from our Sponsor and Physician partners, CTMG is changing the way we convey what makes us different — our unique business structure, superior processes, and cGMP-based approach – all of which assure you Faster Enrollment. Better Data. Period™.   We’ll debut a new website soon, featuring a new logo and messaging, and invite you to […]

What is CTMG’s new “SSRO” terminology all about?

chrat

CTMG will celebrate its tenth anniversary as the world’s first Site Specific CRO (‘SS-CRO’). This unique entity has provided unparalleled speed and certainty to Investigative Site clinical trial completion timelines. As described in the Food and Drug Law Institute’s Food and Drug Policy Forum (http://www.fdli.org/resources/resources-order-box-detail-view/can-fda-accelerate-clinical-trial-timelines-and-completion-using-documented-cgmp-processes-), the SS-CRO model provides design-reviewed processes that translate a Sponsor’s […]

CTMG President and CEO published in the Food and Drug Policy Forum

The document above was posted with permission of the Food and Drug Law Institute. This document can be viewed here.