Our Expertise

Essex hires only top talent with experience, skills, and knowledge in a combination of three areas:

  • Health care, basic and clinical research - understanding the scientific and business imperatives as well as challenges for these domains is key to understanding our clients’ needs
  • Informatics and clinical technology and systems - we understand the technical issues and drivers in the context of our domain expertise, have the skills to implement requirements-driven systems, and act as a bridge between the technical teams and the business users
  • Results-driven focus within a broad strategic framework - our priority is accomplishing our clients' goals as efficiently as possible, but we also understand the big picture. We work with the client to establish project goals that support the broader mission and business objectives of the organization, and provide the change management and communciations needed for success.
Clinical Trial Management

Current CTMS industry trends such as acquisitions, strategic outsourcing, need for operational study data aggregation, metrics and more robust data analytics are continuing to drive standardization and interoperability requirements across the R&D operating model. This includes the need to share data and reporting between systems in an operational manner to more closely manage trial costs and leverage the data strategically.

Some common key CTMS requirements include: budgeting, clinical supplies inventory management, patient management, adherence to GxP regulatory requirements and computer systems validation regulations, and compatibility with other internal (and external) processes and systems.

The Essex team has experience with implementation and development of various CTMS solutions as well as integration across the eClinical Suite (including EDC, CDMS, Safety Reconciliation, Regulatory systems). This includes working in both a project management as well as functional team analysis role to define clinical trial management reporting requirements (including a computer systems validation strategy) and determining adherence to upstream and downstream standards requirements for interoperability. We have also facilitated business requirements gathering sessions and analysis to define reporting and interface data flow requirements across systems

This expertise allows Essex to help our clients move towards true partnership with investigators, faster accrual, better trial data quality, and lower trial costs.

managment

Meet Susan Nonemaker-Cox

Sr. Associate and

CTMS Domain Lead

Susan has over 20 years working in clinical and research IT.  She has managed international Electronic Data Capture (EDC) and Clinical Trial Management System (CTMS) implementations working in a regulatory compliant environment and led the Computer Systems Validation practice for a New York-based management and IT consulting firm.  She is currently supporting the Clinical Trial Reporting Program at the NCI.  Susan holds a Bachelors in Speech Communication with a concentration in Marketing from Shippensburg University.

Clinical Data Management

The most fundamental requirement of clinical research and the ability to gain approval for new drugs and devices is the generation of high-quality data. The advent of Big Data and precision medicine and the focus on reproducibility in research places a bigger burden on scientists to ensure the data they produce is reliable and accessible. Combining large amounts of genomic data with clinical information presents major challenges in both data management and integration activities. Many journals and grant providers now require electronic data submission, and FDA is moving towards even greater standardization in electronic submissions. This environment presents several challenges, including technical choices, but focusing solely on technology will not address the larger issues nor ensure effective planning for the future.

Essex has many years of experience working in the CDMS space, and understands the core needs as well as what has emerged as the space has evolved. Creating solid workflows and efficient processes around data management and the CDMS application are critical to success. Integration with other systems in the clinical and research space are also crucial. This must be combined with an understanding of the regulatory environment, and the impact of technology on the patient. Essex brings a broad and strategic perspective to our clients’ CDMS needs to ensure the most efficient and cost-effective approach, but one that will also provide for future needs.

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Meet Frank Spina

Sr. Associate and

CDMS Domain Lead

Frank has over 30 years of experience working in clinical data management systems, including as a Senior Principal Consultant for Oracle and managing the CDMS Practice for a NY-based consulting firm specializing in Health Care and Clinical Research. He has worked at one of the largest pharmaceutical firms in the world as an Associate Director, representing  both IT and Regulatory Affairs, and has expertise in all the leading, current CDMS systems. Frank holds a Bachelors in Biology from the University of Pennsylvania.

Precision Medicine / Adaptive Trials

As the research community improves its knowledge of the molecular basis for diseases such as cancer, autoimmune and mental health disorders, treatments for these illnesses become more focused on precision medicine. Rather than targeting a specific organ in cancer treatment, for example, a specific gene that may cause cancer in several different organs will be the target of treatment. President Obama has made Precision Medicine a key focus of his agenda, launching a new initiative to further this research early in 2015.

In order to understand molecular targets and gain approval for novel treatments, clinical trials must be focused on clearly demonstrating the link between the genetic mutation and the disease. Essex has supported adaptive clinical trials that targeted specific biomarkers and genetic profiles and integrated clinical data with this information to randomize patients into appropriate trial arms. The heuristic system supporting those trials learned from each patient, providing for expedited results and a much more accurate randomization process as patients moved through the trial. Essex is also supporting a national precision medicine trial that matches cancer patients who have failed traditional therapy to specific, novel treatments targeting specific genes. This knowledge, technical and program management experience allows the Essex team to provide insight and practical support for organizations who wish to undertake precision medicine trials.

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Regulatory Compliance

Regulatory requirements have become ever more complex, and understanding how to navigate the compliance process is critically important, especially when drug or device approvals hang in the balance. Essex has many years of experience supporting customers in determining their needs and validating their systems, including in-depth knowledge of 21CFR Part 11, the Food and Drug Administration Amendments Act (FDAAA) and Disclosure requirements.

Essex has developed a proprietary approach that ensures the appropriate level of compliance. The Essex approach:

  • Emphasizes industry best practices such as Human and Health Services (HHS), Good Automated Manufacturing Practice (GAMP), National Institute of Standards and Technology (NIST).
  • Utilizes a comprehensive Essex Tailoring Questionnaire to confirm the business and validation scope, regulatory compliance determination level, method, deliverables output and estimated work effort to be applied to the client engagement.
  • Assesses the customer needs using both quantitative and qualitative measures, and from the vendor, system, and organizational perspectives

Learn more about the Essex Regulatory Compliance approach.

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Meet Michael Izbicki

Associate

Michael has over 20 years of working experience in pharmaceutical clinical and research IT arena. He has led projects across a wide variety of domains, including global business technology management, metrics and process reporting, software testing and release management, and computerized system validation. He is currently supporting the Coordinating Center for Clinical Trials clinical trials reporting program at the National Cancer Institute to ensure the timeliness, consistency and accuracy of clinical trial results posting. Michael holds a Bachelors in Physics from Rutgers University.

Clinical and Translational Semantics and Data Standards

Within the scientific research community, there are huge shifts taking place. Basic and clinical research is now focused on the molecular basis for disease and on creating targeted therapies that take into account each patient’s unique biology, often called Precision Medicine. This means understanding the genomic basis for disease, and matching specific, targeted therapies to address them. It also means having the ability to do integrated data analysis – combining information from diverse areas of research and treatment, such as animal models, pre-clinical, proteomics, genomics, and clinical care – in order to make connections between the data that illuminate illness and potential treatments. Traditionally, these areas had no real connection – data analysis happened within each domain, and data was not shared across domains – and this is still true today. The situation cannot remain as it is in order for science to realize the vision and benefits of Precision Medicine. The traditional barriers and boundaries between basic research, clinical research, and clinical treatment must be broken down to allow free data flow and sharing between them.

Essex has led and supported numerous data standards and semantics initiatives. Our Project Managers and Subject Matter Experts have led a nationwide collaborative effort to define and implement Standardized Case Report Forms, composed of Common Data Elements, for federally funded cancer clinical trials. Essex Director, Joe Martucci, is an NIH Award of Merit recipient for his contributions to create both standards for the nomenclature of molecular diagnostics and a database to identify markers in NCI-funded clinical trials in support of Precision Medicine. Our team designs and develops systems which incorporate and implement domain models based on CDISC standards such as the Study Data Tabulation Model (SDTM) and the Biomedical Research Integrated Domain Group (BRIDG); as well as integration and interface approaches which leverage HL7 messaging standards.

Read more about the NCI CRF Harmonization and Standardization process.

Visit the Clinical Data Interchange Standards Consortium (CDISC) web site to learn about efforts to create standards for clinical data.