Certus International is comprised of a highly collaborative and supportive team of experts who come together on every project to ensure our sponsors get the very best results.
Certus International’s mission is to be flexible and responsive to our sponsors needs, produce measurable results, and provide industry leading services through high value clinical trial management and monitoring, data management, regulatory consulting, biostatistical analyses, document writing, and imaging core lab solutions for the pharmaceutical, medical device, imaging (MRI, CT, X-Ray, PET/CT, Ultrasound), PET biomarker, nutraceutical, and related industries.
Certus International’s vision is to center our unified contract research organization and imaging core lab via a strong, positive presence in research that impacts the world’s communities. By being open and responsive to change, we aim to provide high-quality services to the industry, while promoting ethical values shared among employees, creating a sound, evolving organization, and producing results that exceed our customers’ expectations.
Certus International is a full service CRO with expertise in infectious disease, oncology, respiratory, cardiovascular, drug and biologic development, process and product chemistry, CMC, QA, and quality system design. Certus is also a leading imaging CRO with decades of experience supporting the development of a variety of imaging agents across all imaging modalities, including CT, MRI, Ultrasound, Nuclear Imaging, and PET.
Since its incorporation in July 1995, Certus International has grown to be an experienced U.S. Contract Research Organization responsible for the successful implementation of hundreds of clinical trials for some of the largest pharmaceutical companies in the United States. It has also provided expert consultation services, helping its clientele successfully navigate FDA regulations and effectively complete marketing applications. Over the years, Certus International has provided a wide variety of services, including clinical program management, quality systems design, biostatistics and data management, product registration and regulation, compliance monitoring, imaging center assessments, and imaging core lab services.
Certus International continues to offer expert services to our sponsors and individual clientele. Presently, Certus International is headquartered in Bedford, New Hampshire and operates a Midwest location in St. Louis, Missouri. Certus employs a staff of experts across several professional fields to include, but not limited to, Regulatory Affairs, Medical Physics, Dosimetry, Biostatistics, Imaging Core Lab Management, and Imaging Clinical Trial Management.
Edward M. Aten, MD
Founder and CEO
Robert G. Wolfangel, RPh, PhD
Vice President, Scientific Affairs
Karen A. Wolfe-Kerker
MS, RAC, CCRA
Vice President, Regulatory Affairs
Deirdre M. Aten
Vice President, Business & Core Lab Operations
S. James Cullom, PhD
Director, Imaging Sciences & Research
Michael P. Culbert
BHS, CNMT, NMTCB(RS), RT(R)
Director, Imaging Core Lab
Our Amazing Sponsors
Who we’ve had the privilege to work with in the past.
What sponsors are saying about Certus International.
Cyclomedica Australia Pty Ltd
“I have had the pleasure of working with Certus since 2007. From day one, the Certus team has performed more like a trusted part of our business rather than the typical CRO association. There are many factors why we choose to continue to work with Certus. These factors include open honesty , active ownership of projects combined with the quality assurance and dedication of their committed team. Certus is an outstanding organisation and a pleasure to work with. Based on my experience I would not hesitate to recommend them to anyone.”
“In particular, our relationship with Certus stands out among those with other CROs because of its depth of integration. Senior staff members from Certus became an inseparable part of our clinical team with the level of trust far beyond the expectations of a typical vendor relationship, strong personal connections, and unmatched dedication expressed as co-ownership of both successes and challenges we have faced.”
Arkadij M. Elizarov, PhD
Siemens MI Biomarker Research
Thorsten Melcher, MD
Varian Medical Systems
“Certus’ understanding of the molecular imaging space and their operational focus gives them the capability to take on a project and then to run with it. Certus' operating with little to no oversight was extremely helpful to Varian Medical Systems, allowing us to focus on our core expertise -- without being concerned about the project. There are talkers and do-ers. Certus is full of Do-ers. Given the opportunity, I would be delighted to work with Certus again and also recommend Certus to anyone considering their services.”
“I couldn’t be more pleased with the Certus Biomarker team. I was very impressed with the excellent attention Certus gave the project, the ownership they displayed in overcoming numerous obstacles and their consistent availability to meet, and work with our team, even on very short notice. They became in integral part of our team, participating seamlessly with both internal and external resources. I wholeheartedly recommend this Certus Biomarker group to anyone needing their unique combination of subject matter expertise and customer focus."