pharmtrace
Delivering Improved Outcomes in Clinical Trials

The development of novel drugs is oftentimes a time and cost-intensive ordeal. Pharmaceutical companies are continually on the lookout for innovative technologies to accelerate clinical trials and reduce the time to market of new drugs. To this end, medical imaging can be a crucial asset in reducing such clinical trial overheads. With an efficient medical imaging program, researchers can not only gain valuable insights on the drug’s mechanism of action, but also acquire efficacy evaluation and safety monitoring data to expedite the regulatory processes. However, medical imaging is often regarded as just another routine biomarker to analyse the responses to a therapeutic intervention. On the contrary, the acquisition and interpretation of images is a coalescence of complex processes that need meticulous analysis and understanding to add value to clinical trial programs.

This is where pharmtrace takes centre stage with efficient strategies and solutions for clinical trials. As an independent CRO, pharmtrace offers flexible and robust CRO services for studies with imaging endpoints, radiopharmaceuticals, and radiological interventional procedures. “We offer end-to-end support for imaging studies, from protocol writing to reporting, interpreting the results, and providing support in regulatory discussions,” states Wolf S. Richter, CEO at pharmtrace.

The company’s proprietary image management platform— ERICA—is an image database and reading system that orchestrates efficient processes and complete transparency for sponsors. The cloud-based GCP-compliant platform enables site personnel to securely upload images to the ERICA warehouse, which are pseudonymized during upload. Further, ERICA allows the customisation of workflows such as image quality control by technicians or medical experts. All image quality control results are transparently stored and subsequently released for the independent read. “Our platform breaks down the complex processes of image management into transparent sub-processes that sponsors can understand easily,” informs Richter. Sponsors can directly access the image status for each patient in the ERICA system 24/7/365.

The value of imaging in clinical trials is huge, but imaging is not almighty. pharmtrace understands the limits of what imaging can provide

Notably, all services offered by pharmtrace are in accordance with the FDA’s guidance for medical imaging in clinical trials.

The biggest differentiating factor for pharmtrace is that, while other CROs primarily focus on the technical aspect of analysing images, pharmtrace also looks at each study from the regulatory perspective and on the defensibility of the imaging read-out in regulatory discussions. This approach helps sponsors to gain a realistic understanding of the potential value and importantly the limitations of imaging in the specific trial context. This approach has been validated in several imaging and radiopharmaceuticals programs where pharmtrace successfully contributed to discussions with regulatory authorities, including EMA, to defend imaging results in a Marketing Authorization Application.

Several firms, including Biotech companies, Academia, Pharmaceuticals, and Device manufacturers, have leveraged the CRO services of pharmtrace to enhance the efficiency of their clinical trials. A case in point is the customer success story of a Biotech company that had licensed a radiopharmaceutical for imaging with Positron Emission Tomography (PET) from an academic group. They were seeking marketing approval for the radiopharmaceutical from the concerned authorities. After being approached by the Biotech company, pharmtrace designed the clinical development plan for them. Additionally, pharmtrace designed and managed the phase two and phase three studies for the client, designed and executed the independent read program, supported the sponsor in preparing the submission documents, and provided support during the approval process.

Established in 2006, pharmtrace has an extensive list of satisfied clients. The company’s team—graduatelevel professionals, scientists, and medical doctors—with their extensive experience in the use of imaging and biomarkers, assist in planning and executing clinical strategies. With several repeat clients and a plethora of new assignments, the company has achieved consistent growth over the years. Going forward, pharmtrace plans to establish representative offices in both the US and Asia primarily to provide a local point of contact but also to further enhance the support services it currently provides and to increase staffing in these regions. “With our scalable systems and topof- the-line consulting services, we are confident of helping more clients achieve desired outcomes in their clinical trials,” concludes Richter.