EXPLORE OUR SERVICES

We can discuss your research goals and objectives, and then offer tailored advice on the resources and strategies needed to conduct a successful study. Whether you're in the early planning stages or looking to optimize an ongoing trial, our experienced team is here to support you every step of the way.

Our team provides evaluation of research operations inclusive of fiscal, coordination, and regulatory. We conduct systematic and impartial assessments of your current research operations by collecting, analyzing, and interpreting data collected to provide recommendations for the improvement of your operations. We can also assist with the setup of new clinical research operations or reform of clinical research operations.

We offer comprehensive study monitoring services to ensure the integrity and success of your clinical research studies. Our team is dedicated to protecting the rights and well-being of participants, maintaining the accuracy and completeness of study data, and ensuring compliance with the protocol, Good Clinical Practice (GCP), and all relevant regulatory requirements.

Our monitoring services can include on-site visits, remote monitoring, and ongoing oversight to identify and address any issues promptly. With our expertise and attention to detail, you can trust that your study is in good hands, allowing you to focus on advancing your research goals.

A visit from the FDA is always stressful. We know; we have been through them!

We assist sites by reviewing key resources and ensuring that all necessary documentation is in order and that staff are well-prepared. During the audit or inspection, we act as a liaison between the site and the FDA, facilitating communication and addressing any issues that arise.
In the event form 483 is received, we will work with your team to respond appropriately.

Our goal is to help the site navigate the audit or inspection process smoothly and successfully.

We offer Protocol Development and Review services, ensuring your research protocol meets all necessary requirements for IRB and GCP compliance. Our team can assist in writing and refining your protocol, ensuring it is feasible and executable by your research and clinical staff.

We provide comprehensive Budget and Contract Management services, ensuring that study budgets are negotiated efficiently and competitively with study sponsors. Our team is experienced in managing the financial aspects of clinical trials, ensuring that budgets are optimized and contracts are processed promptly.

Our regulatory support services encompass the full spectrum of regulatory document development and management. From creating initial regulatory submissions to collecting signatures, submitting documents to regulatory authorities, and handling amendments and event reporting, we ensure compliance at every stage of your study.

We excel at crafting informed consent form that are easy to understand while including all required elements, ensuring clarity and compliance with regulatory standards.

With experience working with both central and institutional IRBs, as well as filing for compassionate use, we are equipped to handle studies of all kinds. We are capable at managing the Investigator Site File (ISF) and can provide documents to study monitors or the FDA as needed, ensuring all regulatory requirements are met with precision and efficiency.

Our study coordination services extend to remote settings, allowing for efficient data collection, remote study visits, and practical assessments. We specialize in coordinating these activities remotely, ensuring that your study progresses smoothly and effectively. Additionally, we handle other remote study coordination tasks as needed, providing comprehensive support to your research team.

In-person study visits can be considered within a reasonable distance of Madison, WI.

Our recruitment and retention services are comprehensive and flexible, designed to meet the unique needs of your clinical trial. We begin by developing a customized recruitment strategy tailored to your study and target population. This strategy may include a combination of traditional methods, such as advertising and outreach, as well as innovative approaches, such as social media campaigns and community engagement.

What sets us apart is our ability to provide direct recruitment services. If desired, our experienced team can take the lead on recruitment, handling all aspects of participant outreach, screening, and enrollment. Alternatively, we can work closely with your team to implement the recruitment strategy, providing guidance and support along the way.

Our goal is to ensure that your study has the participants it needs to succeed. Whether you prefer a hands-on approach or prefer to delegate recruitment to us, we are here to support you every step of the way.

Clinical trials demand a multitude of documents, from case report forms to visit checklists and beyond. Our expert team can craft regulatory and source documents customized to your study's unique requirements. We use original templates and personalized solutions to streamline study initiation.

Our staff training and education services are designed to equip your team with the knowledge and skills needed to conduct clinical trials with excellence. We offer comprehensive training on the study protocol, Good Clinical Practice (GCP) guidelines, study coordination, internal data monitoring, and more.

Our training programs are tailored to meet the specific needs of your team and can be delivered in-person or remotely. Whether you are new to clinical research or looking to enhance your existing skills, our experienced team will ensure that you have the tools and knowledge to conduct successful clinical trials.

By investing in staff training and education, you can ensure that your team is well-prepared to meet the challenges of clinical research and contribute to the advancement of medical science.