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Are your lab’s electronic records
- Attributable?
- Legible?
- Contemporaneous?
- Original?
- Accurate?
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Are your IVRS configurations and customizations programmed correctly?
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How are your clinical teams managing access to investigator site data?
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How is your provider helping you maintain the integrity of your ePRO data?
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Can your provider explain an image’s audit trail as it moves through their process?
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Are your central ECG systems reporting QT intervals correctly?
Confidence in your Preclinical and Clinical Data
Your study depends on systems working. We help make sure they do.
Contact Us Today
Customer Success
In a nutshell, you brought real been there, done that experience which led to a solution that was practical and implementable.
Vice President, Quality and Compliance
Colgin Consulting, Inc.
2014-02-06T00:09:11-08:00
Vice President, Quality and Compliance
https://colginconsulting.com/testimonials/vice-president-quality-and-compliance/
Jamie’s expertise on Good Laboratory Practice (GLP) compliance and Quality Management Systems, both of fundamental importance and necessity in the investigations of the safety and efficacy of drug candidates, enabled my group to leverage her expertise to improve quality and compliance in the research Lab.
Operations Manager
Colgin Consulting, Inc.
2014-02-06T00:09:35-08:00
Operations Manager
https://colginconsulting.com/testimonials/operations-manager/
As an educator, she is very patient and can masterfully explain things in layman’s terms. As a leader, I value her integrity more than anything else.
Senior Director, Quality Assurance
Colgin Consulting, Inc.
2014-02-06T00:09:54-08:00
Senior Director, Quality Assurance
https://colginconsulting.com/testimonials/senior-director-clinical-quality-assurance/
One of the few people I know who can make computer validation feel less scary.
Director, Quality Assurance
Colgin Consulting, Inc.
2014-02-06T15:39:02-08:00
Director, Quality Assurance
https://colginconsulting.com/testimonials/director-quality-assurance/
“Jamie created an integrated auditing process aligned with department’s internal goals and supplier commitments; benefiting both me and our suppliers and creating harmony between supplier and us.”
Colgin Consulting, Inc.
2014-02-06T15:46:41-08:00
https://colginconsulting.com/testimonials/operations-manager-2/
By utilizing Jamie’s expertise my team was able to evaluate and select the right vendor, assess and improve systems compliance and quality in the research labs. Her ability to carry out mock FDA, actual inspections, and recurring periodic audits at our facility helped identify shortfalls in compliance, giving us an opportunity to strive for better compliance. Her advice on validation and corrective actions proved to be a key in the success of our system validation program.
Operations Manager
Colgin Consulting, Inc.
2014-02-06T15:47:38-08:00
Operations Manager
https://colginconsulting.com/testimonials/operations-manager-3/
Lots of people have subject matter expertise. But the ones that stand out - like Jamie - also have good instincts and get to the heart of an issue without wasting time and resources. I have worked with Jamie for many years and her say-do ratio is a perfect 1.
Executive - Software
Colgin Consulting, Inc.
2014-02-06T15:48:30-08:00
Executive - Software
https://colginconsulting.com/testimonials/executive-software/
We found Jamie to have a realistic view of what was achievable in a short period of time as dictated by the sponsor. Strategizing on a way to hit the timelines was a key contribution that most auditors would not be helpful with. Jamie sees the big picture around the clinical trial process.
CEO
Colgin Consulting, Inc.
2014-02-06T15:49:08-08:00
CEO
https://colginconsulting.com/testimonials/ceo/
We were initially challenged with getting a new piece of software in place for a global trial. Jamie was able to facilitate the discussions between sponsor and CRO such that the software could get qualified for worldwide use quickly.
CEO
Colgin Consulting, Inc.
2014-02-06T15:49:36-08:00
CEO
https://colginconsulting.com/testimonials/ceo-2/
Jamie combines a deep knowledge of Quality, Compliance, and R&D in the Pharmaceutical Industry with the pragmatism necessary to achieve effective business processes AND meet regulatory and quality goals. This is an all too rare combination.
Executive Director, IT
Colgin Consulting, Inc.
2014-02-06T15:50:28-08:00
Executive Director, IT
https://colginconsulting.com/testimonials/executive-director-it/
A number of IT processes were changing simultaneously with many stakeholders seeing this as an opportunity to envision multiple ideal processes. To attempt all of these at once would have been prohibitively expensive, taken far more time than was available, and likely not been successful. Jamie’s credibility and pragmatism not only allowed the best outcome, but ensured they path taken was most effective. We were able to save time and cost in excess of $1M/mo.
Colgin Consulting, Inc.
2014-02-06T15:51:36-08:00
https://colginconsulting.com/testimonials/executive-director-it-2/
Our initial project dealt with the development of a complex global system for recording specific data from a large number of departments. The challenges associated with this project were many but throughout the activity Jamie was thoughtful and constructive in her comments, was willing to listen and develop novel solutions and understood the criticality of the deliverable associated with this project.
Director of Compliance
Colgin Consulting, Inc.
2014-02-06T15:52:36-08:00
Director of Compliance
https://colginconsulting.com/testimonials/director-of-compliance/
The encounter with Jamie changed my life. When I first met her I was a general GCP auditor. I joined the Electronic Data Integrity Team lead by Jamie and learned about the world of auditing of computerized systems. Jamie is not only an experienced computer system validation auditor but also a great leader who motivate the team members. I learned a lot about the knowledge of 21 CFR Part 11, computer system validation, and auditing of computerized systems from her. I found that auditing of computer systems was a lot of fun, and that decided me to become a computer system validation auditor in the GCP environment.
Quality Assurance Professional
Colgin Consulting, Inc.
2014-02-06T15:53:04-08:00
Quality Assurance Professional
https://colginconsulting.com/testimonials/quality-assurance-professional/
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Colgin Consulting, Inc.