Research involving the use of radioactive ligands has a degree of complexity and uniqueness different from traditional drug research. These products must undergo complex processes, synthesizing a chemical structure that has the selectivity necessary to target areas of interest. Specifically, after isotope production is completed, the ligand compounding and quality control must be accomplished in a very short time, because of radioisotope half-life constraints.

Biomarker research, particularly research involving positron-emitting radioisotopes, requires careful radioligand synthesis and image acquisition within the Good Clinical and Good Manufacturing Practices regulatory framework. The challenges with radioligand synthesis and imaging are complex to address. Through the use of PETbiomarkers, Certus provides many pharmaceutical sponsors with a platform to determine a clinical site’s suitability to participate in a trial, readiness to begin a trial based on the synthesis technology and imaging performance, and on-going verification of radioligand dose and image quality. A non-uniform production and imaging platform produces inconsistent imaging results, which can contribute to potentially invalid trial results.

As a company, Certus has been focused on PET imaging agents since 2002, but our staff’s experience began in the 1970s. Our people helped develop many radiopharmaceuticals now in use, developed, and managed the imaging science associated with the use of imaging agents and designed and managed a variety of clinical programs supporting drug development. We provide our clients with extensive drug development experience, radiochemistry and synthesis design, quality control methods development, imaging science, protocol design, clinical program design, and regulatory guidance. Certus has compiled CMC, non-clinical and clinical information into research Drug Master Files (DMFs), (IND Applications, commercial ANDA/NDA applications, and interfaced with regulatory agencies to develop approval strategies.

Pharmaceutical companies and research sites need an effective biomarker research platform to support drug development, and Certus provides that. The Certus team directs the development of radiochemistry, analytical methods, procedures, production, and general laboratory operations. This direction incorporates the applicable international commercial and research Good Manufacturing Practices (GMP) requirements for PET drugs, providing products that sponsors, sites and patients can be confident meet safety standards. Certus also oversees application of imaging science to achieve imaging study endpoints. Certus will design and implement the clinical protocol and submit the necessary regulatory approval applications.

The sooner you contact us regarding your PET clinical trial, the better. That way, we can provide consultation to design a clinical plan, and manage radioligand and imaging platforms that will contribute to your drug development success. But, it is never too late. If you have encountered problems in your current program, we can work within your project and still help you achieve success.

You may have internal resources to manage clinical trials or are considering a clinical research organization (CRO). You may also have a separate core lab managing image acquisitions and reads.

But, who is monitoring radioligand production?

And, who is coordinating all three areas?

The standards, guidelines, and regulations governing radioligand production, imaging science and clinical trials are extensive, complex, and prescriptive. Installing a quality assurance program meeting cGMP and Good Imaging Practices requires scientific as well as regulatory experience. Candidate clinical trial sites may not have the skills, or do not have the person-power to complete these tasks. Investigators and sponsors may not be aware that the synthesis development, radiochemistry process development, radioligand dose compounding, and other unique characteristics of dose preparation for clinical trials have been overlooked. Additionally, the continuing development of new applications and innovations in imaging collection requires a continuing expertise in image acquisition, analysis and interpretation, all within an increasingly complex regulatory environment. Very few groups have the talent and experienced people necessary to direct all necessary aspects of radiopharmaceutical research. Certus International has the talent, the experience, and knowledge needed.

Beginning with developing a regulatory strategy and designing a protocol, we consider the unique challenges nuclear medicine clinical trials bring. Consistent with industry standards, regulations and guidelines we build quality assurance frameworks clinical trial sites can actually implement, and we monitor the radiochemistry and imaging processes in the same way we monitor the trial. Certus’ clinical support group manages clinical trials, our imaging science services supports imaging studies with site assessments and our radiochemistry and synthesis services assure radioligands meet necessary quality, purity, and strength needed. All of these services are directed under a biomarker research approach. Our interdisciplinary teams make Certus’ biomarker research group uniquely qualified to perform site suitability, site selection, site readiness, and on-going data integrity verification. They understand that achieving imaging endpoints requires PET radiochemistry, synthesis, and imaging working together to a trial goal.

We believe that by understanding and coordinating the clinical, production, and imaging aspects of a clinical trial, a number of critical improvements can be made. Regulatory requirements can be met, making clinical and regulatory related problems less likely; time is saved, by efficient and effective synthesis, image acquisition and by streamlining communications; money is saved, since time is saved; and clinical trial subjects are protected. Managing all of these items ensures your program runs smoothly and with fewer headaches.