Certus' mission is to provide outstanding quality and high value clinical trial management, monitoring, data management, regulatory, biostatistical, writing and imaging core lab services within the pharmaceutical, medical device, imaging (MRI, CT, X-ray, PET, Ultrasound) , PET Biomarkers, nutraceuticals and related industries; and to be flexible and responsive in meeting our clients' needs; and produce measurable results.
Certus' 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 meet or go above and beyond our customers’ expectations.
Patients experiencing a medical event are often overwhelmed and without new diagnostic technologies, would continue to be lost. Our goal is to make a positive difference in the lives of people by helping to give loved ones diagnostics and therapies that impart a sense of security, confidence, and quality. Relatives and friends of Certus employees have directly benefited from the products we helped bring to market, and the comfort and clarity imparted to patients in their most vulnerable situations by products we helped bring to market is our greatest satisfaction. Knowing that these products could benefit our loved ones in the future is what motivates us.
We take pleasure in doing things differently and like devising simpler, faster, and superior regulatory strategies. The FDA is a group of educated, dedicated people, hard working in their commitment to safety and willing to listen to alternative opinions. Their goal is to make safe and effective products available to people, while keeping the US a leader in innovation. Sometimes they are mischaracterized as adversarial, but that has not been our experience with Imaging and other Divisions, so our working style is much more collaborative.
We always strive to make the perfect regulatory submission; one that understands exactly what FDA requires and is approved in record time. It hasn’t happened, yet, but with every project, we get a little closer. The target is a moving one, because they are learning, just as we are, and raising the bar. The people at FDA are very knowledgeable and want products they feel comfortable for their family to use, just as we do. We are all working towards the same goals. The increasing complexity and fluctuating target that the perfect submission presents is a challenge that we enjoy.
Our people work hard. It is ingrained in our personalities. Because Certus is a small company, employees are like family and working well together is important, so we are very selective with whom we hire. Most of Certus’ staff has worked together for over 15 years. This reduces risk, improves efficiency, and further differentiates Certus. The Certus team has worked across competencies on imaging, diagnostic, therapeutic drugs, biotechnology and device products. We work closely with each other and with sponsors, as trusted partners, streamlining procedures and maximizing both teams’ available resources.
With two offices, one in Chesterfield, Missouri and one in Bedford, New Hampshire, effective communications are extremely important.
In 1995, Edward M. Aten, MD, founded The Aten Group, based in St. Louis and quickly established itself as a premier niche clinical research consulting company. With the addition of world-class talent and decades of experience in all facets of clinical research, the Aten Group renamed itself Certus International Inc. in 1997 and continued to be a positive partner working with sponsors in many areas including oncology, cardiovascular, CNS, and diagnostic imaging.
At Certus, our Project Managers utilize a hands on, flexible management approach. Certus Clinical Project Managers serve as your main study contact, supported by the clinical services staff, striving to keep the study on your schedule and within budget. We ensure the quality of the CRAs on your study, because they are responsible for so many important aspects of your clinical trial.
Biomarker research requires careful radioligand synthesis and image acquisition within the Good Clinical Practice (GCP) and Good Manufacturing Practices (GMP) regulatory framework. Certus provides pharmaceutical sponsors with a platform to determine a clinical site’s suitability to participate in a biomarker trial, readiness to begin a trial, and on-going verification of radioligand dose and image quality. A non-uniform production and imaging platform produces non-uniform imaging results, which can contribute to invalid trial results.
Medical images are the foundation to the successful clinical development of diagnostic imaging agents and many therapeutic drugs that rely on images for efficacy endpoints. With an integrated CRO and Core Lab, you no longer have the frustration of trying to locate images. You call one company and get the information you need on your clinical and imaging data; this can reduce cost and headaches. Certus also oversees application of imaging science to achieve imaging study endpoints.
All of our customized regulatory services can be used on an individualized consulting basis, or for your entire project. Regulations and guidelines form the framework upon which all of our services are built and past clients have praised our regulatory knowledge, accessibility and dependability. From developing a regulatory strategy to promotional labeling, you can be sure your project is carried out efficiently, accurately and as projected.
Our statistics department is active in all appropriate aspects of our clinical studies. This involvement ensures a deeper understanding of your needs. Involving PhD level statisticians, as early as protocol development, in your clinical trial is not only standard, but also one of the most efficient ways to realize long-term savings. Our statisticians are in house and instrumental to our every day operations.
Thank you for your interest in Certus International. We would like to make the best use out of our resources, and think you do the same. Along those lines, we have provided a "printer friendly" version of our website, hopefully saving you paper and ink/toner. We will implement similar efficiencies in your clinical program. Please don't hesitate to call with any questions.