Global Clinical Research
Veranex offers best-in-class clinical and regulatory expertise, helping move your MedTech innovation to market.
What We Offer
Veranex can help if you are in the process of moving your device to the market, looking to expand your claims, or working to comply with emerging post-market data collection requirements. Our in-depth regulatory expertise and clinical trial execution capabilities will ensure you’re checking the right boxes.
Our team members have worked as senior leaders at major MedTechs, at the FDA, and across technical committees and working groups. They have written medical device standards globally and navigated regulatory hurdles across the industry. We can offer expertise with 510(k) and De Novo Submissions, Early Feasibility Studies, Investigational Device Exemptions (IDEs) supporting Premarket Approval (PMA), Pivotal Trials, International Review Board (IRB) requirements, as well as post-market studies across numerous therapeutic areas.
MedTech is Our Focus
We guide medical device manufacturers through all steps needed for clinical research, making the journey from early device development and working with regulators, through to study design, enrollment, and effective clinical trial execution.
Furthermore, our QMS, based on ISO 14155 and ISO 20916, is specially tailored to the requirements for clinical investigations of medical devices to ensure protection of human rights, avoidance of error, and worldwide acceptance of the study results.
As a global, medical device exclusive CRO, managing MedTech studies is what we do. We know the challenges associated with the conduct phase and how to navigate them in the best way to ensure subject’s rights, safety, and well-being, as well as the scientific integrity of the study.
In addition to our full-service offering, we can also support isolated activities such as monitoring, auditing, or clinical investigation training.
Through our vast experience of global medical device studies, we’ll guide you through each step and ensure the proper closure of your study. Did you for example know that the EU MDR requires that the study report shall be made publicly available, resulting in that many manufacturers choses to develop two reports to fulfill both EU MDR and ISO 14155 requirements whilst keeping the publicly available information to a minimum?
Need additional support? No problem, as an end-to-end MedTech service provider we can support you with everything you need, also outside a clinical investigation setting.
Get end-to-end research support, when and where you need it. From study design to clinical investigation reports and publications, our team is here to support you.
- Identification of clinical endpoints pertinent to safety and/or performance of the device
- Definition of clinical study type (e.g. superiority, non-inferiority, equivalence)
- Sample size considerations
- Statistical Analysis Plan (SAP) definition
- Compilation of the Clinical Investigation Plan (CIP) in compliance with the Good Clinical Practice (GCP)
- Assembly of Investigator’s Brochure (IB)
- Selection of clinical study site
- Structure of Electronic Case Report Form (eCRF) architecture
- Compilation of other relevant components of the Trial Master File (TMF)
Study Submission and Registration
- Interactions with regulatory authorities, ethics committees, and Institutional Review Boards (IRBs)
- Submission of Clinical Trial Application (CTA)
- Registration of a clinical study in national registries
- Management of amendments
- Conducting initiation visit
- Study monitoring
- Study close-out
- Support with inspections
- Implementation of a Data Monitoring Committee (DMC)
- Classification of Adverse Events and device-related deficiencies
- Serious Adverse Event (SAE) reporting
- Periodic safety reporting
Auditing and Supplier Qualification
- Audit of clinical study site
- Audit of clinical procedures
- Audit of mandated Contract Research Organization (CRO)
- Identification and qualification of service suppliers (CRO, logistics, insurance, etc.)
Clinical Data Management (CDM) and Data Analysis
- CDM Plan compilation
- Database set-up
- Clinical data analysis
- Clinical Investigation Report (CIR) compilation / Clinical Study Report (CSR)
- eCRF solution
Are you a pharmaceutical customer looking
for clinical study support?
Our global presence is essential to access diverse patient populations, ensuring more representative clinical investigation samples and robust data collection. It also enables us to navigate complex regional regulations, streamline approvals, and accelerate time-to-market for your MedTech product.
We work with standardized processes for seamless collaboration between our global teams which means you can expect a high level of data quality and operational efficiency. Having a global presence gives us unparalleled access to specialized talent and local expertise, leading to successful clinical investigation design and patient recruitment strategies.
GLOBAL CLINICAL RESEARCH
114 35 Stockholm
Landsberger Strasse 302
Ronda de Sant Pere, 16
Utopicus Building, 5th floor
San Jose, California
224 Airport Parkway, Suite 250
San Jose, California 95110
Secunderabad – 500015
Entreprenörsstråket 10, GoCo House
Chemin de Rovéréaz 5
Av des Dessus-de-Lives, 2
5101 Loyers (Namur)