Services
Our medical device CRO services
OUR SERVICES
Consulting
With the accelerating rate of innovation and increasing complexity of medical technologies, medical device companies are looking for support to guide them through challenges on the path to regulatory approval.
At Visionware Clinical, our experts will work with you to plan your medical device path from concept to commercialisation. We can guide you through concept and discovery and support your preclinical trials to your medical device prototype. As a medical device CRO, our focus is to advise on an agile pathway to approval in accordance with the device risk-based classification. (Note: as your device risk classification increases, so do the regulatory controls and precaution measures).
Medical devices development stages:
Device discovery and concept
Feasibility trial
Prototype
verification testing, safety and efficacy trials – risks vs. benefits analysis)
Regulatory review
Post market trials/surveys
OUR SERVICES
Data gathering
- The device do not compromise the patient’s health and safety
- The device performs in accordance with its intended use
- The benefits of use overweigh the risks (any undesirable effect)
To demonstrate that your device complies with these principles, scientific evidence and clinical evaluation is required. This can be done by obtaining clinical data through a clinical trial.
We will help you design and conduct your First In Human (FIH), feasibility and pivotal trials and support you through any verifications of the device design and variations as needed. Once sufficient data of device performance and risk is established from the clinical trials, we will support you through the medical device regulatory review process.
For your regulatory review you will need to maintain all conformity assessment documents that are appropriate for the category and class of your device. All documents and data collected from the conducted clinical trials should be retrievable and comply with regulatory standards, showcasing a safe and effective medical device. After launching of the device to market, we will be able to establish a post-market clinical trial for monitoring the device performance and safety.
Our data analysis experts will update your risk and benefits analysis after each phase of trialling your medical device, helping to build your medical device risk profile.
Your clinical trial data will be gathered via paper or electronic Case Report Form (eCRF). Visionware Clinical will create, set up and manage your paper or Electronic Data Capture (EDC), as needed.
OUR SERVICES
Medical Writing
- Clinical investigation plan and statistical trial design
- Investigator’s brochure
- Instructions for use
- Patient informed consent form
- Patient information sheet
- Trial flyers
- Questionnaires/e-questionnaires
- Case report forms (CRF)/e-CRFs
- Any applicable study plans
OUR SERVICES
Clinical Trials
Planning and designing your clinical trial is an important and crucial step. We will work with you to optimise your study design so it is time and cost-effective while proving feasibility, safety and effectiveness of the device.
We offer a full range of services including:
- Determining whether your product is a medical device
- Establishing a local entity – The sponsor or its representative must be residing in Australia in order to have their unapproved therapeutic goods imported to Australia for the conduct of a clinical trial
- Regulatory guidance in Australia and New Zealand
- Tailoring the strategy for a successful clinical trial (from early phase to post-market clinical trial)
- Clinical trial registration via clinicaltrials.gov or ANZCTR
- Identifying key opinion leaders in the pertinent therapeutic area
- Identifying competitors both locally and globally
- Establishing and writing all study documents required for ethics and governance submissions
- Appointing medical monitors, clinical event committees or data safety monitoring boards as applicable
- Medical device clinical trials management through all stages, from trials feasibility, initiation to close out and conclusion according to applicable laws and regulatory standards
- Support software as a medical device
- Ethics submissions (private or public sector) including annual progress reports
- Governance submissions
- Clinical Trial Notification (CTN) to competent authority (The Therapeutic Goods Administration (TGA) in Australia and Medsafe in New Zealand. – We will create a TGA Business Services (TBS) account as your authorised agent with the TGA
- Advise you on your medical device labelling and packaging requirements
- Sites/institutions selection and contracting
- Sites qualification including cadaver workshops/training if applicable
- Developing trial plans such as:
- Project plan
- Monitoring plan
- Safety and risk management plan
- Investigational product handling plan
- Trial master file plan and communication plan
- Covid-19 contingency plan as applicable
- Sites initiation including preparation of initiation materials such as:
- Investigator site file
- Patient file
- Pharmacy file
- Site initiation presentation slides
- Sites monitoring including risk based monitoring
- Sites close out including end of trial notification to ethics, governance and competent authorities
- Safety reporting per local requirements
- Data management including interim analysis reports
- Trial field support if applicable (this is mostly needed with implantable medical devices)
- Trials finance management
- External audits and quality assurance
OUR SERVICES
Our regulatory experience
We have experience with the Australian, New Zealand regulators and legislative bodies for the conduct of clinical trials.
Our experts will guide you through the requirements and process required for the inclusion of your medical device in the Australian Register of Therapeutic Goods (ARTG) so it can be legally imported into, supplied within or exported from Australia. We will navigate through those requirements per published and advised steps by the TGA.
The TGA regulates new medical devices in accordance with:
- Pre-market assessment based on an assessment of risks against benefits, considering the levels of risk and measures for risk control, any reported adverse events and undesired effects over time, toxicity and seriousness of the medical condition for which the Investigational Product (IP) is intended to be used
- Post-market monitoring and enforcement of standards and;
- Licensing of Australian manufacturers and verifying overseas manufacturers’ compliance with the same standards as their Australian counterparts