Service Brochure
Sponsor delegation for IVD first-in-human clinical performance study and evaluation
Empower your clinical studies with our completely managed outsourced IVD clinical study sponsor package
In the critical phase of first-in-human medicinal product trials, attention to detail, compliance and efficiency are crucial. By delegating your IVD clinical study sponsor responsibilities to ARC, you gain a trusted partner with the expertise and resources to seamlessly initiate and manage your study, while you are still in control and continue acting as a sponsor.
Key Components of our IVD Clinical Study Sponsor Delegation Package
Under our complete managed outsourcing model, we will work as your pharma clinical trial sponsor extension for your IVD performance study, with clearly identified integration points.
Systems and people will connect seamlessly to deliver on the overall objectives of your IND/IMP and IVD studies.
As your IVD clinical evaluation sponsor we will take care of:
We conduct thorough due diligence and selection processes to identify the most suitable diagnostic and laboratory vendors for your study.
We develop regulatory strategies tailored to your specific needs, prepare and submit all necessary documentation to ethics committees and regulatory bodies, ensuring timely and accurate compliance, and navigate regulatory requirements to expedite approval processes and reduce time to first sample tested.
We oversee the IVD performance study, assign a dedicated clinical study lead and manage the regulatory binder (eTMF), using either our system or yours.
ARC IVD Clinical Study Sponsor Comprehensive Services
We provide a full suite of services tailored to support your first-in human (FiH) trials involving IVDs.
Our completely managed outsourced IVD study sponsor package includes:
Our team specializes in creating custom-designed IVD performance study protocols tailored to meet your unique research objectives. We also conduct comprehensive feasibility and risk assessments, to help you identify potential challenges and mitigate risks. Our main objective is to ensure a smooth and efficient clinical trial process.
We handle regulatory submissions with expertise, ensuring timely approvals and strict adherence to all necessary standards. Additionally, we take care of securing ethical committee approvals, prioritizing the protection of participants and maintaining the integrity of your study.
We strategically select and qualify clinical study sites to optimize the quality and efficiency of data collection. While our ongoing site management and monitoring ensures that these sites adhere to the protocols and regulatory requirements consistently, maintaining the highest standards throughout the IVD performance study.
Our approach to data collection, management and statistical analysis is rigorous. We provide detailed and transparent reporting, presenting findings in a clear, understandable, and actionable manner, allowing you to make informed decisions based on reliable results.
Helping you throughout the IVD clinical evaluation process
Why choose ARC as your clinical study sponsor partner
We are a trusted market leader in regulatory, quality, and clinical operations, with extensive experience supporting the full clinical development life cycle of precision therapies for global pharmaceutical companies. As a full-service CRO, we are fully equipped to meet IVD clinical trials sponsor responsibilities and obligations while, our commitment to excellence, ensures that we consistently deliver high-quality results.
Advantages of working with us as your IVD clinical evaluation sponsor:
Leverage our extensive experience in managing studies of clinical trial assays in precision medicine trials.
Plug into our completely managed outsourced sponsor processes to reduce administrative burdens and to expedite your IVD performance study start up. We help reduce the time your team spends on IVD considerations so they can focus on what they do best.
We know how to navigate complex, overlapping regulatory requirements with ease and manage compliance risks to ensure that your patients and their safety are kept to the fore.
We will handle the complexities to allow your team to concentrate on core research and innovation.
As a full-service CRO, we are fully equipped to meet IVD clinical trials sponsor responsibilities and obligations
Why delegate Sponsor Responsibility to ARC?
- Competence in this ‘niche’ area
- Real world experience in IVD sponsor responsibilities
- QMS process know-how
- Sponsor oversight and management
- GCP monitoring
- Pharma sponsor extension
- Clear roles and responsibilities
- Regulatory and compliance experience
- Extensive clinical monitoring experience
What our customers have to say:
”Partnering with ARC was a transformative decision. Their deep knowledge and expertise of regulatory requirements in global markets for IVDs in precision medicine trials, along with their open and collaborative approach, ensured a smooth and successful trial.”
A leading, global pharmaceutical company
