Partners

Your Site. Our Eyes.

IMARC believes monitoring means having eyes everywhere. Whether it is communicating with upper management, following through on issues and maintenance, tracking trends during studies, or creating customized monitoring tools to boost performance, IMARC stays on top of it for you. With IMARC Monitors protecting your interests from Day One, your data integrity is ensured, compliance requirements enforced and patient safety entrusted.

Finally, Being Audited Pays Off.

With FDA and International inspections on the rise, so are stress levels of everyone involved in clinical studies. IMARC provides the specialized independent auditing support services you need to survive today’s rigid regulatory requirements — not only to ensure compliance, but also to protect patients. Approvals are not just granted. They are earned. IMARC has experience preparing even the most sophisticated sites – domestically and worldwide – for FDA and International inspections. That includes everything from compliance checks and coaching – to – regulatory reviews, organization of documents, and more.

You Need to Reach the Finish Line. Like Anything Else, that Takes Training.

Your study may be short staffed. It may be operating on a tight budget. Yet one thing it cannot afford to be is derailed due to lack of experience or knowledge. Quality research training is in demand because the increasing needs of clinical research demand it.

IMARC’s Innovative Training Program: Improve Your Research Studies

Even with great improvements in clinical research education in the last decade, we’re still falling short. The FAIR Shake™ technique takes an otherwise complicated maze of requirements and breaks them down into four simple areas that can be applied to clinical research questions.

Balanced Thinking + Inventive Ideas = Boosted Productivity for Clinical Studies.

These are just some of the value-added components IMARC injects into our consulting services. Need a qualified expert to bounce ideas off or challenge your thinking? Tap into our knowledge base and ensure that what works gets done and what doesn’t work gets bounced. Another factor that can make or break your study is unexpected issues that pop up. IMARC Consultants have the monitoring and auditing experience to adapt quickly, react proactively and intelligently balance your priorities. Finally, we give you the boost you need to function at the highest level. Have a special request? We get it done. Stuck with inexperienced staff? We can train them. Hit by personnel turnovers? We understand how to staff and stabilize.

Clinical Research Training That Takes You To A New Level of Proficiency

IMARC University is a series of affordable online training and continuing education courses designed to prepare you and your team for clinical research compliance. These courses cover many aspects of the clinical research process, from FDA regulations and GCP standards to adverse event reporting and advanced monitoring topics. All courses can be taken at your own pace. We even offer customized training to meet the needs of your team.

Be Ready For The Next Step In Your Career

We offer courses designed to train professionals for various roles within clinical research, including monitors, investigators, and research coordinators who are all crucial to ensuring your research is compliant and completed in a timely manner. Our role-based packages also offer continuing education credits! Whether you’re looking to transition into a new role in clinical research or you’re training new members of your team, these courses will thoroughly prepare you for the work you’ll do on site and between site visits.

Become An Expert At Your Research Site

Perhaps you’ve already been in the field for several years, but you want to become proficient in a new area where you haven’t had a lot of experience. Build monitoring skills or learn about preparing for FDA inspections. Maybe you’ve been away for awhile and you need a refresher – try our Foundation Package for an overview of the FDA regulations, GCP and much more. Our training packages are structured around several disciplines critical to clinical research compliance, including an introduction to good clinical practice, basic and advanced monitoring courses and FDA preparation. Our training packages also offer continuing education credits!

Never Stop Advancing In Your Field

Whether you want to advance your knowledge in a particular area or need to earn contact hours, our individual courses give you the flexibility to choose your area of interest and learn at your own pace. With just one course, you’ll be well-versed in the area that interests you most—whether it’s adverse events reporting, human subjects protection or Good Clinical Practice. You’ll hear examples of some of the challenges real clinical research professionals encounter in the field every day and learn from their experiences.

Our experienced biostatistics team will take ownership of your needs.

Our top-tier biostatistics team provides full support to our clients by helping to determine the most efficient pathways to product approval. Our team of experts has an in-depth understanding of a number of key therapeutic areas, including a deep knowledge of the evaluation histories of similar studies and the distinct statistical issues that affect therapeutic pathways. The biostatistics team at SDC is committed to providing the very latest in statistical thinking. To accomplish this goal, we stay abreast of the latest statistical methods and related regulatory preferences. Our statisticians are experienced in interacting with the FDA and other regulatory agencies and pride themselves on the ability to effectively communicate on behalf of our clients.

Where positive engagement and innovation meet integrity and quality

When it comes to clinical trial success, data integrity is key. With a world class technological infrastructure and a team of top managers and directors, SDC is committed to providing the highest data quality, integrity and security. Through frequent coordination with clinical operations, SDC provides a seamless flow of data and a constant level of communication to ensure that projects meet deadlines and milestones, and keep clinical trials on track for timely conclusion. Our data management experts also fully understand and comply with Good Clinical Data Management Practice (GCDMP) and Clinical Data Interchange Standards Consortium (CDISC) standards. Whether the trial is a large international study or a single center proof of concept trial, SDC understands how crucial it is to get the project running efficiently. Clinical data management plays a key role from study startup through closeout and our team works seamlessly with clinical operations to meet all of the critical milestones of a sponsor’s project. SDC consistently meets or exceeds sponsor expectations in regards to both timelines and quality.

Flexibility and accessibility to meet your needs

SDC offers iMedNet as our primary eClinical solution deployed through a strategic partnership with MedNet Solutions. iMedNet provides a comprehensive, yet highly configurable technology to successfully manage clinical studies from start to finish. SDC is proud to provide this next generation technology built from the ground up using a forward thinking architecture which allows for all system components to be integrated under a single platform. iMedNet provides innovative tools for efficient management of your study.

We give you market insights to guide your technology from concept to commercialization:

• Go-to-Market Process Mapping
• Competitors
• Regulatory Process
• E-Reputation
• Identify Target Segments
• In-Market Performance Tracking
• Business intelligence tool with more than 2,000 sources
• Medtech Expert Communities

We create your customized roadmap based on the insights we gain from extensive market intelligence.

Pre-launch expertise to define your path to market:

• Market Assessment
• Product Development
• Clinical Trials
• Clinical Validation
• Regulatory Approvals
• Reimbursement & Pricing Strategy
• CE Mark
• Targeted Market Introduction
• Early Market Feedback
• Endorsements
• Clinical Applications Training & Support

Whether your device is still in development or already has CE mark approval, we can help guide you through to successful commercialization.

Marketing & PR focusing on peer-to-peer communication

Working as an extension of clients’ internal teams, our account managers work directly with key opinion leaders and physicians to reduce the demand on a clients’ time, efficiently delivering high-quality work:

• Marketing
• International congresses support
• User meeting organization
• PR
• Medical Writing
• Relationships with Opinion Leaders
• Medical Education
• Practice Development
• Practice Marketing

A highly focused plan to drive sales growth after launch:

• Direct commercialization in France, Germany, UK
• Commercialization through distributor partners in Benelux, Italy, Spain, Switzerland
• Pan-EU Supply-Chain Management
• Clinical Applications Management
• Technical Services
• Post-Sales Management

Our careful planning combined with our targeted approach gives you a proven method and an efficient market interface to create the commercial momentum. We are committed to your commercial success.

Medical Communications and writing

Our communication services help you and your innovation stand out with the audiences that matter most:

• Marketing
• Media
• PR
• Medical Writing
• Relationships with Opinion Leaders
• International congresses