Essex provides professional services to academic medical centers, government entities, and biopharmaceutical commercial companies that are engaged in scientific and health care research. Essex focuses on existing, new, and emerging technologies, and on creating the integration needed to share information across the translational research domain.
Key to this effort is the ability to understand and achieve the current, tactical goals of an organization while setting the stage for long-term, strategic goals. This is critical in research and healthcare, where pragmatism must balance vision. One example of this is Meaningful Use Requirements, where organizations must work quickly to meet the short-term requirements, but with the intention of adding strategic value over the long-term.
The Essex Team has both breadth and depth of skills, expertise, and experience to ensure the success of bioinformatics and IT projects.
Select one of our service areas on the menu to the left to read more.
The success of any IT and informatics project will be based not on the quality of the idea but the ability to execute and bring the idea to fruition. Many projects fail, or deliver way less than the users actually need, due to a lack or operational ability.
Essex Program and Project Managers have many years of experience in the Life Sciences ensuring that won’t happen. Using industry Best Practices along with a set of Essex tools and techniques (IKEs) compiled from hundreds of projects, our Program & Project Managers move projects forward, consistently managing risks, ensuring alignment with goals and strategies, and managing all stakeholders to create a harmonized team and coherent and cohesive project plan. Our PMs bring value throughout the life of any project, and deliver ROI through increased efficiency, a comprehensive communications plan, and rigorous risk management.
Meet Neesha Desai
Neesha has over 15 years of experience in health informatics and project management. She has managed the development and implementation of a Protocol Tracking Management system for the National Institute of Neurological Disorders and built and maintained a Software License Tracking System for the Intramural Program at NINDS. She is currently supporting the National Cancer Informatics Program at the NCI working with the National Clinical Trials Network and academic institutions to facilitate the implementation of standardized data elements in a CDMS system to promote science, patient safety, efficiency and the performance of meta analysis across the clinical trials community. Neesha holds a Bachelors in Bioinformatics and Information Technology from James Madison University and a Masters in Project Management from George Washington University.
Excellent analysis is often the difference between a system that meets the needs of the scientific and business users, and a system that does not. Scientific and business users often have an intuitive understanding of what they need, but lack the ability to translate that into a set of specific, comprehensive, and comprehensible requirements.
We hire professionals who are career analysts, with many years of experience and the unique set of the communications stakeholder management skills required to translate between the users and the technology team. Our analysts are expert at working across teams and domains, ensuring that the documentation clearly and accurately reflects the requirements of all the stakeholders – whether for purchase of an existing system, or providing technical teams with the specifications they need to customize or build a solution from scratch. Working through the whole project lifecycle, from initial concept to usability testing and deployment, Essex analysts are there to support the team in the creation of the informatics and IT tools that facilitate the clinical trial and health care enterprise.
Meet Sandy Lightbody
Sandy has over 30 years of IT experience in the tele- communication and pharmaceutical industries. She has managed implementation of in-house developed software and customized vendor application projects. Her roles have ranged from gathering and documenting business requirements, authoring functional specifications for technical developers, completing functional and user acceptance testing, system project documentation and conducting end user training. Sandy also has experience in critical care nursing and respiratory therapy. Sandy has a BBA in Information Technology from Bernard Baruch College, City University of New York.
Organizations must constantly evolve in order to meet the changing needs of the marketplace and keep pace with technology advances. This need to adapt is amplified in the world of research, health care, and bioinformatics, where technical progress drives scientific progress, and vice versa. The focus on the molecular basis for disease, the advent of ‘omic “Big Data”, and the need for integrated analytics across organizations, data sets, and geographic distances are forcing organizations to look differently at how they work, how they are structured, and how they prioritize their activities.
At the same time, change is still difficult, for organizations and for individuals, and must be managed to be successful. Essex understands the multiple, parallel steps required to move an organization towards a new vision, while continuing to function effectively and ensuring that people are not thrown into uncertainty and chaos. We have worked with large and small organizations, to put in place the strucure and processes to move through periods of instability, provide staff with resources to maintain a positive work environment while defining the future state. This process includes careful assessment of current state and recent history; development of a vision, strategy, objectives, and organizational structures; change management planning that includes milestones and communications at critical junctures to ensure staff understanding and buy-in; and tactical necessities, such as workflow planning /streamlining, development of new approaches or service areas, and alignment with leadership activities across functions. In addition, Essex has experience creating the metrics to measure outcomes and assess the success of strategies and tactics. This is a critical part of any change management approach, but is often overlooked in favor of a focus on cultural and other “soft” issues.
Read an article in Harvard Business Review about the four key factors in Change Management.
The goals of Precision Medicine have drastically changed the meaning and context of systems integration.
While evidence-based medicine is the true goal, most institutions continue to struggle with even the basic integration required to bring clinical research and care data together, providing improved outcomes and clinical decision support. The clinical research systems that are using targeted therapies more frequently simply do not talk to the EHRs that house critical information for patient accrual on clinical trials, or to glean the insights that could change a clinicians medical choices.
Essex engineers have many years of experience in integration and with different techniques and methodologies, including Agile Development, DevOps, and the Semantic Web. Like their Program Management and Business Analyst counterparts, Essex technologists and architects have applied that expertise in the domain of the Life Sciences. This ability to understand not only the technical challenges, but the data itself, allows the Essex Team to create the analytics and consolidated data systems that provide the critical information clinicians, scientists and researchers need to progress healthcare and improve patient outcomes.
If you'd like to know more about how computers and software actually work, read this terrific and engaging article from Bloomberg Business: "What is Code?"
The past several years has seen a huge rise in the percentage of the work force that works virtually, driven by the ease and availability of high-speed teleconferencing. More and more, virtual, global teams are working together across time zones, cultures, and location. Managing time zones, understanding cultural differences, and building a cohesive team are all challenges in this environment.
Stakeholder management in co-located teams presents its own challenges, including managing personality differences and moving teams to consensus while ensuring everyone is heard and acknowledged.
Essex has successfully managed virtual and face-to-face teams. Key to this success is an effective Stakeholder Management and Communication Process, which enables us to overcome those challenges and successfully manage and facilitate any process or project, regardless of the industry. Our process ensures:
- Clearly defined roles for all team members, reducing conflict and time wasted on determining who is responsible
- Expedited turnaround time to document and share project artifacts
- Effective interactions across the team, regardless of location
- Facilitated process that leads the team to understanding of issues and decisions, and consensus where appropriate
Read more about the Essex approach to Stakeholder Management and Faciliation.
Meet Christina Warmington
Christina Warmington began her career with over six years as a United States Air Force Active Duty Airman. After serving her country, she worked in a variety of roles for Lockheed Martin Aeronautics and IS&GS including as a meeting and stakeholder facilitator. Christina is currently a technical administrator and business analyst supporting the National Cancer Informatics Program and the Coordinating Center for Clinical Trials at the National Cancer Institute and a large academic medical center. Christina holds an Associates Degree in Aerospace Technology from the Community College of the Air Force, a Bachelors in Information Systems Security, and a Masters in Management from American Military University.
IT and informatics organizations often face challenges when it comes to communicating the value they add as well as the best ways to work with them. Scientists and clinicians are not trained in informatics, so they lack the ability not only to create informatics tools or algorithms, but even to understand the process. Often this results in the informatics team being included in a scientific project too late in the process, which is inefficient and costly. This also creates additional challenges, such as setting appropriate objectives and goals in the absence
of true collaboration with the scientific community, and how to ensure the informatics staff understands their priorities and imperatives.
Essex has broad experience helping IT and informatics organizations develop strategic communications plans, working
to create true, collaborative partnerships with the scientists they serve and supporting IT staff in their ability to adjust to the customer needs. By ensuring that the researchers are engaged and educated about the informatics services and the significant value of collaboration from the start of a project, the organization can align its priorities and goals to the actual scientific goals of its customers.
Read about the ABCs of Strategic Communications,on the Evalutaion Exchange, an online periodical from the Harvard Graduate School of Education.
Technology firms are often focused soley only the task of building a useful and usable system. But if an application is not properly tested, users not properly trained, and integration and sustainability needs not adequately addressed, the system will likely fail.
Essex has managed many large-scale deployments of clinical research systems, ensuring that the users’ requirements are well-defined and functioning, that they have been tested and approved in UAT, and that all stakeholders are prepared for the new system in terms of training and workflow. We have developed long-term support plans that ensure the system will support user needs and scale up as necessary.
In a highly-regulated environment such as clinical research and drug development, knowing that your systems have the appropriate security, processes, and documentation in place in case of an audit is critical. This is true regardless of whether you are using a commercial system or one that was developed in-house. The Essex Validation and Regulatory Compliance Team utilizes a tailored, structured, and rigorous approach to systems validation that includes a set of assessment tools and checklists designed to reduce the regulatory burden while ensuring compliance. The focus of the team begins with an analysis of business needs and requirements, which are then mapped to regulatory frameworks to determine the best approach for each system or component.
Read more about the Essex Validation approach.
Read the FDA's
guidance onGeneral Principles of Software Validation