Clinical strategy Regulatory requirements: where do you want to do your clinical trial and what legal impact has that on your trial?
Clinical requirements: your clinical protocol has to deal with the standard way of treatment. This standard might vary from country to country or even from hospital to hospital. Deviation from the clinical standard might impact your study considerably in recruitment and costs.
Reimbursement requirements: Third party reimbursement is of vital importance for medical device companies. Collecting this data during your clinical trial that can support your reimbursement strategy.
Marketing requirements: a company cannot make marketing claims unless those claims have been tested. Moreover the medical audience is getting increasingly skeptical of marketing tools but they are receptive to data from credible sources. Regulatory Affairs Study Design 'Document' flow Investigator selection - Investigator compensation and Hospital Agreements MEC submission CA notification Device supply coordination Clinical Monitoring Monitoring Adverse Device Event reporting Auditing Statistics & Data management Data base development Reporting Related services We can assist you with: OTHER SERVICES
- Pre-Clinical Biocompatibility services are offered through our alliance with Bioscan.
What do you want to achieve and what you need to accomplish that in the most cost-effective way.
Of what legal impact is the design and place of your trial (Whom to notify? How fast is MEC approval?)
Factory designs the ideal clinical study to answer the questions that you have about your device, be it safety, performance, efficacy, or marketing claims. The design is made in accordance with selected standards: EN540 and/or ICH-GC.
Design of CRFs
Control of essential documents
Factory has a large Investigator network in many different surgical specialties allowing a speedy selection process. Aside from selecting reliable and respectable investigators there are some more factors to consider when making a balanced choice:
- Training of investigator
- Training of investigator staff
- Presence and training of Clinical Trial Coordinator
We pro-actively assist your selected investigators in submitting the study to the appropriate MEC. This considerably shortens delay periods to start the study.
Does the Competent Authority of the country where you perform your study need to be informed? What is the timing of this notification and how does it impact the start of your study?
We will coordinate the European supply of your medical device if needed. This helps you reduce the administrative tasks associated with it while keeping tight control over your inventory.
You have taken outmost care with the design of your product and you know the handling characteristics of your product. But you are not the one who will be using it, not even in a clinical study. Especially during a study you want to be absolutely confident that it is used in the manner you intended it to be used. That is why we have clinical monitors who can assist during surgical procedures to insure that the device is used correctly and simultaneously noting any deviations during the procedure.
Reliable data is the backbone of each study. Our monitors are not only here to check the paperwork. They are able to monitor during any surgical procedure. They make sure that both the clinical cases and the data derived from those can stand any audit. And because they can communicate on the same level as the surgeons the consistency of the clinical paperwork is better guaranteed.
We assist you and your investigators in Adverse Event Reporting according to the local rules and study protocol. We follow up the Serious Adverse Events with the investigators on medical so no vital information will get lost or misinterpreted.
With our clinical research background and years of experience we can assist you in pre-auditing or auditing your investigational sites or your own clinical department.
Biostatistics should be considered in the design phase of the study. In the ideal study the biostatician is needed most before you start your study, not afterwards. Sample size calculations, biostatistical protocol development and review, randomisation code generation, and statistical analysis are to be implemented in the study protocol.
Data collection, review, clarifications and entry
Data analysis and reporting
Study end-report
Technical Papers
Scientific Papers and abstracts
- Product Innovation panels
- Sales training and instruction
- Education of Product Specialist
- Regulatory services are also offered through our daughter company Q-MED.
- Post-Marketing Surveillance & Vigilance: European and USA authorities require you to monitor the performance of your devices systematically and to implement corrective actions in case of failure. Through our alliance with PSI we can assist you in organizing and managing these systems.
- Medical Device Consultancy: we assist venture capital investors and National Aid Funds in evaluating the costs and feasibility of clinical study programs