Factory CRO offers top consultancy, regulatory, and clinical trial services as well as data management and statistics.
Clinical Evaluation Report (CER)
Although the new Medical Device Regulation in the EU is almost officially approved, MEDDEV 2.7/1 has already been updated according to the expected requirements. Per 29 June 2016, the updated MEDDEV has been put into practice without transition period, and Notified Bodies therefore already implement this in their approval process. That means that all devices (from class I to III), whether they are new or already on the market for a long time, are required to have up-to-date CERs. Note here that MEDDEV 2.7/1 rev. 4 requires evaluators to have knowledge of research methodology, information management, regulatory requirements, medical writing ánd minimum 5-10 years experience in the relevant field. Factory has an expert team of medical writers that has this knowledge and experience and that can help you compiling these reports making sure you do it right the first time so you don’t loose time and resources. We can help you designing a protocol for reviewing existing literature data, new clinical data, and all your internal reports (including your post marketing surveillance data) to relate to your risk analysis. Clinical Evidence
Procedures for FDA submission and approval are complex, requiring different strategies for each type of medical device or IVD. Adequate knowledge of the requirements of each access route is therefore essential. We have an extensive knowledge pool available, helping you through each step of the submission process.
Postmarketing Surveillance (PMS)
The transition from clinical development to marketplace introduction is critical to the success of a product. Post-marketing surveillance studies can give you the valuable information you need to optimize your product's potential and gain competitive advantage.
Factory has expertise in the design, conduct, analysis and reporting of PMS studies. Results from well-designed PMS studies can strengthen your marketing and sales efforts. Factory is eager to work with you to achieve the scientific credibility of PMS studies and to maximize your product's exposure.
We are well acquainted with CE-marking studies and can assure that your study can be designed and controlled to meet the demands of Notified Bodies. Our strategic establishment in Europe with ISO9001-2008 certified Standard Operating Procedures that comply with the ISO14155 standard will provide you great advantage.
Our monitors/clinical research associates guarantee up to date knowledge of your trial status at each participating hospital. Our monitoring activities consist of:
Pre-study & initiation visits
Source Document Verification
Close out visits
Trial document handling
Reporting of safety information
Our MDs are experts in the safety evaluation and handling of Serious Adverse Events that are reported during the trial follow up period.
One of the services that distinguish us from conventional CROs is our clinical monitoring service. We are proud to have experienced technical experts in different clinical fields who can provide monitoring of clinical procedures so that you can verify that your device is used as you intended.
International Clinical Trial Rescue
We are proud to offer our early-detection program designed to help medical device companies correct poorly designed clinical trials, effectively saving the study from ultimately being rejected by FDA or European regulators. We developed a rescue assessment program that can be implemented in as little as three weeks. It includes an audit of the collected data, discussions with senior management about study objectives, review of protocols to identify trouble areas related to enrollment, regulatory compliance, and expert advice on a recovery plan. Finally we can assist with the implementation of the rescue plan.
Payer and market research
Physician and facility coding and reimbursement strategy
AMA CPT Code application submissions
Payer coverage policy reconsideration requests
Clinical Trial Reimbursement
Navigating the pathway to insurance reimbursement and coverage can be difficult for both the sponsor and the site. Our dedicated team of reimbursement representatives can provide sponsor and site support with questions regarding claims submission, appropriate coding and reimbursement.
Product Coding and Reimbursement
Our experienced team of Certified Professional Coders understands physician, outpatient and hospital inpatient payment methodologies and provides clear, consistent reimbursement support for manufacturer marketing/ sales teams and customers.
Coding and reimbursement guideline development
Manufacturer specific customer coding and reimbursement support hotlines
Single product to full product line support
With technology evolving at a pace faster than payer coverage it is necessary to provide support to product consumers. Our patient advocacy support services make it possible to access new procedures and technologies.
Protocol / Study Design
Our extensive experience and knowledge can help you plan a optimal study design. In addition to our internal expertise, you can get direct market feedback through meetings with panels of clinical experts. Let us be your bridge to the key opinion leaders and surgical experts throughout Europe.
FDA Regulatory Strategy
The FDA regulatory procedures are complex, though imperative for US market access. An efficient review and approval of your clinical trial, or a short route to market clearance, can only be obtained with adequate knowledge of the procedures employed at the agency and a well-designed regulatory strategy. Factory's team has a broad and in depth knowledge on FDA requirements and procedures and can help you design a regulatory strategy specific for your device.
Timelines and Budgetary Control
Controlling development timelines and budgets are essential for companies that want to bring a medical device to the market. Factory’s control systems give you all the information you need to keep you informed and stay in control of the process, every step of the way.
European Regulatory Strategy
In many cases it is easier, faster and cheaper to obtain your CE mark (which provides marketing approval for Europe) than an FDA approval. And in most cases, equivalent clinical studies are less expensive in Europe than in the USA. Many of our clients have exploited these two advantages in order to begin marketing their product in Europe prior to FDA submission. Further, Factory can often help clients conduct European studies, which accelerate FDA submissions. We would be happy to provide a free consultation about your European regulatory strategy, without any future obligation. We can assist with Notified Body selection and negotiations.
Our data-managers are part of the team to make a medical device study a success. They actively participate in the design and implementation of a trial, using their vast experience and specific medical device knowledge to serve the goal of the study. Whether they help Principal Investigators and study nurses who prefer paper/digital CRFs or full EDC, they will adapt their process to guarantee that a clean database can be locked almost immediately (days, not months) after Last-Patient-Last-Visit.Our data-management activities consist of: