Study Phases

Increasingly sponsors are seeking partners who can provide a multitude of services as opposed to niche service providers. The advantage of our cross-platform imaging expertise is that we are able to conduct innovative science in early phase trials while simultaneously conducting efficient late phase studies. Through the adherence to the methodologies of Lean Six Sigma, our organization has become more flexible, nimble, efficient and readily scalable to manage projects from pre-clinical through phase 4. Our dedication to customer service and focus on operational proficiencies has led our customers to increasingly select us as their imaging core lab of choice for both early and late phase trials.

Pre Clinical

With strong scientific roots tracing back to the research environment of the University of Rochester, VirtualScopics has extensive experience assisting sponsors in the discovery phase of trials. As a far less invasive means of study, imaging provides a window into the mechanism of action of development compounds. Through the benefits of imaging, scientists can test the method of action and obtain critical information about efficacy, thus enabling them to lay the foundation for a more streamlined clinical trial process from Phase 1 through 3.

VirtualScopics' Pre Clinical experience includes:

30+ Animal studies - dog, sheep, goat, cow, horse, rat, mouse, rabbit and other models
30+ Method studies
Pre-clinical model development
Biomarker validation
Pre-clinical to clinical technology transfer
Disease progression, device performance, and compound efficacy using MRI, CT, PET, and other modalities
Focus areas: musculoskeletal, oncology and medical devices

Phase I & II

Over 30% of new compounds fail in late stage testing. Therefore, finding those failures, and successes, earlier can play a critical role in determining a sponsor's pipeline priority and developmental strategy. By discovering the biochemical and metabolic interactions in early phase testing, sponsors can reduce the amount of late phase failures and better prioritize their pipelines, thus reducing the amount of human capital and financial resources wasted.

VirtualScopics conducts quantitative imaging that provides sponsors with biomarkers that characterize the pharmacokinetic and pharmacodynamic profile of an investigational compound. In other words, imaging can provide indicators as to the efficacy and toxicity of a compound. In a typical trial this information is not assessed until Phase 2, but if employed earlier in a study, quantitative imaging can provide sponsors with this crucial data much earlier.

VirtualScopics built their strong scientific reputation in the industry through their work in early phase studies. Many large imaging core labs do not possess the scientific expertise or operational flexibility to properly manage early phase trials. Contrastingly, many academic institutions lack the bandwidth, processes, FDA compliance or ability to handle multi-site trials. Meanwhile VirtualScopics possesses the scientific capability to incorporate novel imaging biomarkers while possessing a flexible and adept team that can proficiently manage all size studies.

Early phase study benefits of quantitative imaging:

Proves or disproves mechanism of action or concept
Provides a direct window into the effects of a drug candidate
Detects efficacy signal and measures safety
Confirms maximum tolerable dose (MTD)
Reduces necessary trial sample size through increased precision and reproducibility; fewer subjects = lower trial costs; smaller trial sizes = quicker enrollment and faster results
Enables sponsors to make key adjustments in mid-trial
Development and use of novel imaging biomarkers
DCE-MRI can offer early prediction of tumor volume changes
Complex segmentations allow the review of thickness, volume, and surface area changes of a lesion or defect
Transparency and willingness to share our radiology systems and methodologies with our sponsors
Flexible read paradigms - occasionally a sponsor requests a specific reader based on specialized area expertise. We are open to working with these remote readers and setting up a regulatory compliant arrangement.
Provides information for basis of a quicker "go/no-go" decision - reduces late stage attrition

Phase III

In Phase 3 trials our imaging solution is relied upon by sponsors to confirm proof of efficacy and safety in larger patient populations. However, as studies transition into later phases, science takes on a less significant role as the focus shifts to efficient trial management in the final step toward regulatory approval.

Our commitment to the principles of Lean Six Sigma enables us to easily transition from early phase to late phase study management. Our site management and project management teams have established themselves as experts in working with trial sites to accelerate image retrieval to minimize delays and training data to minimize acquisition errors. Our proven ability to deliver agile and qualified trial management results in our sponsors receiving accurate data that meets the pre-determined objectives and milestones.

Late Phase benefits:

Site readiness - accelerated site training eliminates impact on trial timelines and cost
Personal service - establishing a strong working relationship between our teams fosters open communication and greater understanding of client needs
Multi-site experience - we are well versed in the many challenges of establishing harmonization and standardization across multiple imaging sites
Global experience - More than 2,500 imaging sites trained across more than 40 countries
Low data loss rates - our data loss rates of 4% (compared to literature which notes typical loss rates of 25-30% across imaging studies) are among the lowest in the industry due to our ability to back out motion and other artifacts that would typically require a re-scan.
Our PPD Alliance provides full-scale study services

Phase IV

VirtualScopics continues to offer value to sponsors' development programs even after their drug has been approved. We provide Phase 4 services to sponsors in label and population expansion studies, as well as comparative effectiveness studies between a newly approved drug and the current standard of care for a specific disease. We also use imaging to evaluate selected baseline laboratory parameters in post marketing studies. The reproducibility of our measurements, quick on-boarding of imaging sites and our adaptive management solutions are the key tools sponsors seek when partnering with us in Phase 4 trials.

Rescue Trials

While there may be numerous reasons that necessitate a study rescue, our objective is always the same: continuing your study toward completion while minimizing delays and interruptions. Flexibility, responsiveness and adaptability are traits that serve us well in our ability to step right in and assist sponsors.

We will quickly meet with your team to understand the circumstances that necessitated a change in imaging providers. We'll assess the current status of your study, discuss your expectations, then strategize a plan to get your project back on track. We will choose a team specifically for your study and they'll immediately implement the project plan. The study will progress with open, proactive communication from our team so that we can earn your trust and develop a strong working relationship throughout the remainder of the study.