Clinical Trials, Research & Discovery Solutions

Virant Diagnostics is able to assist your company to perform high complexity clinical laboratory testing for your research and clinical trial studies whether it’s a therapeutic or medical device. We have expertise that will cover a broad spectrum of services, that includes protocol development, IRB submission, patient recruitment, laboratory testing, regulatory and medical writing.

CLINICAL TRIAL AND RESEARCH SERVICES

Development: We are able to be involved in your company’s mid-preclinical phases to commercialization and beyond. We have experience the details and infrastructure of early development through late-phase trials, regulatory requirements, and market access.

Customization of services: We will skillfully navigate your compound/medical device through any developmental obstacle and regulatory process. We will strategically align your company with the appropriate regulatory and industry requirements ensuring pre-market FDA approval, setting up for a successful launch. We will be able to assist you with the post-market approval process as well.

Project Management: Our project and operations managers will guide your company through the entire development process, partnering with you for all your needs. We will develop efficient and thorough project management plans that are aligned and in lock-step collaboration with your company’s goals. We will clearly identify key milestones that will be executed on-time and within budget.

Making Preclinical and Early-Phase Transitions Efficient

Our Bioanalytical Laboratory and expert scientist will focus on your project timelines, ensuring rapid sample processing and data generation. Our cutting-edge technologies, advanced clinical and analytical services allows for extremely high quality of results. From protocol concepting and scientific consulting to IND support, and from data and project management to multi-site, first-in-human pharmacokinetic and clinical monitoring, our preclinical and early-phase services take the guesswork – and the hassle – out of moving from preclinical to early clinical phases.

Full-Service Clinical Trial Support

Once your clinical research is underway, our team of experts will diligently manage your compound/drug or medical device development program with consistent communication with your company to ensure your data, budget, and efforts fulfill the strategic plans, focused on keeping the milestones on track.

Regulatory, Commercialization, and Beyond

As a partner in the clinical trial development of your company’s product, we understand that there are many goals along the way, achieving proper execution of various strategic targets. Through early and ongoing discussions with regulatory bodies, and strategic planning throughout the entire development program, we help ensure your company’s product/molecule is properly setup for the rigorous regulatory review process. We can support post-marketing studies such as real-world evidence gathering, patient-reported outcomes studies, health economic and outcomes research, economic dossiers and modeling, safety surveillance, literature reviews, and other scientific-medical endeavors.

OUR EXPERTS ARE EXPERIENCE IN RARE DISEASES, GENETICS, INFECTIOUS DISEASES,ONCOLOGY, ENDOCRINOLOGY, CLINICAL MICROBIOLOGY AND NEUROLOGY

Our team of medical and scientific experts are able to maximize the impact of all collected clinical and laboratory data, allowing for traditional scientific and fresh perspectives on study design and patient recruitment. We help investigators build their recruitment plans, advise on patient eligibility, address any medical or safety questions and concerns, share experiences from other sites and discuss protocol deviations to help prevent reoccurrence.

We understand and engage key opinion leaders and regulatory advisors
We actively work with patient advocacy organizations
We have robust electronic data systems
We focus on the importance and patient engagement in the clinical trial
Patient Support Services for patients and their families