IMARC Research, Inc. is an ISO 9001 certified global medical device CRO founded in 1999 by Sandra Maddock who had a passion for patients and a belief that there was a better way to provide oversight for clinical research studies. These principles have helped fuel IMARC's steady growth during its 20-year history and remain core pillars for the company. As a full-service medical device CRO, IMARC assists sponsors with conducting well-controlled, compliant, clinical research studies. IMARC can offer leadership and support to clinical teams at any point in the clinical life cycle, helping them navigate the complexities of earning approval.
Chroma is the largest worldwide provider of power testing instruments and systems including electrical safety testing equipment, programmable AC/DC Power Sources, AC/DC Electronic Loads, Digital Power Meters, MultiMeters, and Automated Testing Systems. Hipot or dielectric withstand testing instruments manufactured by Chroma are used for conducting electrical safety tests on electrical components and products to make certain they are in compliance with IEC, UL, TUV, CSA, EN, and other electrical safety requirements. In addition, these instruments are designed for general product or component testing as well as complex medical safety testing (60601-1) ensuring human safety and product reliability. Chroma's safety testing equipment is built with an emphasis on automation, traceability, and efficiency for medical manufacturers.
Milliman is one of the largest independent actuarial and consulting firms in the world and has pioneered strategies, tools, and solutions for more than 60 years. We are recognized leaders who have helped shape significant changes in the markets we serve.
Hull Associates LLC is a specialized global reimbursement strategy firm focused on medical device and diagnostic technologies. Founded in 2007, the firm helps companies navigate reimbursement challenges around the globe with market access and reimbursement assessments and strategic consulting; evidence planning; data analytics and health economics; pricing analyses; and assessment and validation of clinical trial design. With 50+ seasoned partners worldwide, Hull Associates collaborates in the development and execution of comprehensive strategies for product launch and reimbursement in the US and among major global markets including the Americas; Asia Pacific; Northern & Eastern Europe; The Middle East; and Western Europe.
Since 1992, Health Policy Associates has been providing high quality consulting services to the medical biotechnology community. We serve our clients on an exclusive basis in areas of product development, regulatory and clinical consulting, strategic planning, clinical operations(full-service CRO), operational staffing, and venture financing. Health Policy Associates accomplishes this by providing a personal, adaptable, and comprehensive approach to solving complex problems on multiple levels. We are highly specialized in bringing the best product development, regulatory, and clinically focused strategic thinking in the industry to clients throughout the world. We deal with some of the most unique and complex products in development. We have a unique connection with the medical device venture capital community evaluating and managing investment opportunities and providing them with exciting, cutting-edge medical device opportunities. Health Policy Associates comprehensive and streamlined approach ensures project efficiency and excellence from beginning to end.
Making the Tools of Medicine Run Smoother. Advanced medical device coating services for lubricious, hydrophilic, hydrophobic, superhydrophilic, superhydrophobic, and non-thrombogenic coatings for demanding medical devices. Formacoat provides a 'one-stop shop' for a wide range of coating technologies for various applications from different coating vendors. Our wide array of coatings provides advanced capabilities for coating lumens, ID/ODs, balloons, films, wires, foams and complex device shapes. Core device capabilities include coating catheters, introducers, guide wires and components, including balloons, tubing and wire and a variety of other medical devices, as well as other non-medical device articles for unique and challenging applications. Additional custom capabilities exist for devices and materials include reel to reel, spool to spool film, solvent casting, and foam or screen mesh applications that benefit from a medical device coating. Formacoat is ISO 13485 Certified.
EngiLifeSciences is a transformational consultancy firm that delivers faster leaner compliance, organizational excellence and the agility to adapt to market conditions through innovative and proprietary solutions. These solutions include EngiLifeSciences MEV GRID, which strategically analyzes, architects and delivers Maturity, Efficiency & Visibility throughout our clients organizations. EngiLifeSciences 3PO MODEL then analyzes, architects and implements organizational excellence by eliminating waste, creating streamlined and replicatable processes and modifying behaviors. This uniquely positions firms with a competitive advantage, the ability to thrive and be profitable in volatile and changing markets. EngiLifeSciences portfolio of clients includes high profile companies within the Medical Device, Pharmaceutical and Biotechnology Industry.
mdi Consultants, Inc. has been providing FDA regulatory consulting services to the FDA regulated industries since 1978. We have assisted companies understand the FDA regulations and pathways for compliance. Our clients range from the Start-Up to the Fortune 50 companies. We obtained FDA clearance on over 3500 applications covering all areas of medical device industry. Assisting with FDA regulatory strategy, 510(k) applications, setting up quality systems (MDSAP assistance) and dealing with FDA inspections and the aftermath. Our clients are worldwide and mdi looks for long term relationships with our clients working with us for over 35 years.
Marathon Products Inc. is a manufacturer and global supplier of data collecting devices used for documenting environmentally sensitive products during transportation and stationary applications.
Their goal is to become the world's leader in designing , manufacturing and distributing sensor based products for monitoring environmental conditions.
Strategikon Pharma is an expert-led, innovation-driven, agile, emerging new leader in the clinical trial business management space. We are a Woman-Owned Small Business, and cloud-based technology platform company funded by Silicon Valley and made up of industry veterans with experience on both the Sponsor and CRO side. Clinical Maestro is our flagship product; it is a fully digital system for clinical trial planning, budgeting, sourcing, vendor management and financial performance metrics management.
Our Clinical Maestro solution is absolutely unique in the industry – there are just no substitute products out there with the same breadth of novel solutions and collaborative infrastructure that have the potential to transform the industry. This is largely because we are not trying to build a product to sell to pharma companies or CROs, rather we are trying to solve an age-old problem that has plagued the industry with inefficiency since the introduction of computers and email. Our vision incorporates moving away from traditional Excel-driven manual methods of budgeting, sourcing and vendor management and metrics and into the age of workflow automation and artificial intelligence. Clinical Maestro brings order to the RFP process by assembling and organizing inputs from all stakeholders to create a shared digital standard. A good visualization of the current state of the industry is that each Sponsor and each CRO is playing their own musical instrument, their own song, in their own style, alone, in a corner. Clinical Maestro brings all these players together in unison to create a beautiful symphony. Together, with the right technology and tools, we believe we can get there.
We have seen amazing innovation start to flourish in the business processes around clinical development. I call it the Administrative Revolution of clinical trials. These include simplified, digitized and automated solutions for vendor discovery and payment, site and patient compensation, and whole process evolution for planning, sourcing, financial performance metrics and engaging with vendors such as Clinical Maestro’s digital Transaction Room and Governance dashboards. Furthermore, artificial intelligence has a mega role to play in our ability to use predictive analytics to better mine one’s own data sets and collective, anonymized data sets such as Clinical Maestro’s Intelligence Bank and Data Trove. Other areas that will change the game include using AI for at-home dosing, patient access and patient engagement. I am personally very excited by the use of video communication technology and localized contract staffing models to reach patients in remote areas. Lots of exciting things are happening that should propel our ability to deliver life-saving and life-improving therapies to patients in need.
Early adoption; with any new technology solution there tends to be a hockey-stick pattern of adoption – no one wants to be first and no one wants to be last. Having been founded in 2016, Strategikon Pharma is still a young company in a very conservative, slow-moving, and highly regulated industry. Our solution is so novel, so mind-blowing in its ability to disrupt current highly manual processes and deliver efficiencies that we are finding clients need time to digest the potential impacts. These include politicized corporate challenges such as replacing old, underutilized, embedded legacy applications, and even threatening existing low-productivity empires. We are addressing major industry pain points and are confident that our product is the absolute best on the market. Therefore, we are highly focused on Advocacy and Thought-Leadership to help educate the market, engaging the most open-minded and technology-savvy movers and shakers in the industry to champion our system, and of course building ongoing strong investor backing to help us weather the long sales cycles. In short - we aren’t going anywhere and are committed to bringing the future forward!
1. Inertia – there are many numerous new technologies available on the market that could really help solve industry problems but most are being brought forth by small, innovative companies that need to survive in order to move the dial. Many larger drug companies are taking a passive approach and expecting vendors to solve their internal issues with very broad, customized solutions that will require M&A activity. I worry that by waiting for these small players to consolidate into larger-scale providers, the industry to lose some of the innovation edge and nimble service benefits that small organizations can deliver today. 2. Conservatism – similarly, as much as we like to think of the pharmaceutical industry as being “high-tech”, we really haven’t changed that much in the past 40 years or even 20 years. In fact, much of the advances in communication have created more busywork and distractions. Each of us industry professionals need to look within at how our own daily behaviors and working practices could be improved to drive greater productivity and impact. We believe without a return of focus to analysis, strategy, action, performance and change, drug development will continue to elongate which drives up cost and risk. We owe it to patients to innovate and evolve. 3. Balance of Power – in my prior role at a Top CRO, I experienced the integration of commercial services into clinical solution strategies. This was a mega eye opener for me to start to appreciate this completely other world, and I will never forget the words of our CEO who led the assembly of this model back in 2011. He talked about the future being one in which drug companies are paid not for supplying drugs, but for achieving Health Outcomes. This, along with the introduction of greater efforts to hear the voice of the patient and the growth of formal patient advocacy groups, will finally start to change the dynamic towards one where the real customers of our industry achieve a greater balance of power. I believe this connection to the communities we serve and the accomplishments we deliver is essential for our industry to remain relevant and thrive.
It is important for us to attend CTIP because we have an excellent message to share and are eager to seek out other like-minded professionals who are thirsty for innovation. We hope that CTIP will help us expand minds while making new friends and partners in the process.
My name is John Lehmann, Director of Business Development for IMARC Research. I have two primary roles with IMARC Research. First, is creating business opportunities for the company. Next, is handling all marketing related activities for the company. Having these dual roles has been helpful in helping driving awareness and building growth as a top Medical Device CRO.
I joined IMARC in 2009 and have a passion for promoting our company’s values, expanding our relationships with sponsors and attracting new accounts. It has been rewarding to see IMARC grow and prosper over time. I am looking forward to attending MDIP and meeting new contacts and learning about their clinical support needs.
Risk Management is key in planning a medical device study. Thinking through the potential pitfalls and then making mitigation plans to help minimize their likelihood is essential in running a well-controlled clinical study. Having a robust site selection process can also help set the study up for success. Ensuring that sites have an established clinical research infrastructure, experienced personnel, an engaged principal investigator, and access to the target patient population will help ensure that study is run in a compliant manner and that study milestones can be achieved.
Helping the sponsor and sites run a well-controlled, compliant clinical study starts with writing a solid protocol. When drafting the protocol, the following “tips” will help decrease the likelihood of non-compliance issues globally:
• Incorporate human subject protection requirements specific to your clinical trial that meet both FDA and international requirements.
• Consider what the standard of care is throughout all regions and draft the protocol accordingly. If standard of care is different from region to region, allow flexibility for those differences in the protocol.
• Avoid mandating requirements for Institutional Review Board (IRB) or Ethics Committee (EC) Reporting, as each IRB/EC may have different requirements. By mandating it in the protocol, it becomes a regulatory requirement with which not all sites can comply.
• Define in the protocol which requirements the study is being conducted under and train each site accordingly.
Monitoring of clinical studies is a regulatory requirement and is necessary for ensuring that quality data is submitted to regulatory authorities. Auditing, while not a regulatory requirement, provides another layer of oversight that focuses on process-level issues. Auditing can be used throughout the study to identify non-compliance trends and note improvements that could be made in order to improve the overall quality of the clinical study. Auditing done earlier in the process adds more value in that sponsors and sites then have sufficient time to address any identified non-compliances to ensure they don’t recur.
IMARC suggests auditing the trial master file at the following key milestones:
• After site initiation activities have occurred
• About halfway through the study
• In preparation for regulatory inspections
For sites, IMARC suggests auditing them after about 25-50% of their subjects have been enrolled.
IMARC’s robust training program based solidly in US and international regulations situates us to have a positive impact on human subject protection and the overall compliance of a clinical study. In 20 years, none of IMARC’s sites or sponsors have ever received an FDA warning letter. Made up of project management, data management, monitoring, auditing, and others, IMARC’s clinical trial teams work side by side with sponsors to identify potential risks, establish mitigation strategies, implement those strategies, and communicate throughout the process with both sponsors and sites to ensure human subject protection and worldwide acceptance of quality data.
New global post-market requirements for clinical data may prove to be a burden on both sponsors and sites, and could be a big game changer in the next 5-10 years. Coming up with an electronic means of collecting the necessary data without sacrificing the overall quality of the data may be essential in meeting these requirements. CROs may play a bigger role in helping to alleviate the added burden at both the sponsor and site levels.
This will be IMARC’S first year attending MDIP and we are eager to introduce IMARC Research to new companies and contacts.
It’s also important to stay abreast of current topics in clinical research and to network with others who are experiencing similar challenges.