Consulting Services

Consulting Services

ER Squared offers broad array of e-clinical consulting services covering a variety of topics, including:

Operational & Strategy Consulting

At ER Squared, we assist our clients in improving their clinical research and development processes. We do this through strategy definition, system selection, change management, system implementation, and leveraging the entire solution portfolio to turn data into actionable information. In doing so, we build relationships with our clients that allow us to assist them in deriving maximum value from their investments, but more importantly maximizing the value of their data. Rigorous business analysis in support of clinical research systems and operations must be grounded in thorough understanding of clinical development operations. While many of the well-known, large-scale consulting providers are quite effective at providing technology consultants; depth of knowledge and experience in the industry is often lacking. ER Squared differentiates itself from the competition by employing industry experts with years of operational and leadership experience. Our staff has served in biopharma positions actively involved on projects very similar to what they are assigned to as consultants. This experience is the cornerstone in providing strong business analysis services to our customers.

Contact us today to get the advantage of our experience.

eClinical Strategy

eClinical is more than just EDC. It requires a holistic view of the entire clinical trial process, an honest assessment of your business goals and understanding how technology can be used to support your goals. We specifically start with your business goals, because a successful eClinical Strategy must be business centric rather than technology centric. It must balance the need to optimize operational processes while also laying a foundation for growth and inclusion of additional integrated processes and systems.

The definition of eClinical has been evolving. Not long ago, many thought of eClinical as synonymous with EDC. However, most would now agree that while EDC is important, it is just one component of a holistic strategy. It is critical that firms look at the entire clinical trial process and take an honest assessment of business goals to determine how technology can be used to support these goals, what technologies best fit your strategy and how to prioritize various components.ER Squared believes that now, more than ever, experienced consulting services are critical whether you want to develop a fully integrated platform or to add new point solutions to an existing platform.

Our process and technology experience spans clinical trial development and execution. Particular domain expertise includes: structured study design, clinical trial management, electronic data capture (EDC), clinical data management, data warehousing, clinical programming, and change management encompassing system and organizational changes.

Contact us to understand how technology can support your business goals.

Clinical Data Repository

A key component that many firms are now addressing is a Clinical Data Repository or Data Warehouse. A cross functional clinical data repository enables the efficient capture, transformation, consolidation, reporting and archival of clinical data. Every organization has an assortment of legacy data requiring consolidation and/or transformation in order to maintain usability of this asset. Beyond the legacy data, any project must also factor in expected growth in data volume and accommodation for various data sources including unstructured data. Getting the data in is only the start, without the ability to extract the data in meaningful ways to create actionable information, the system would be more aptly referred to as data graveyard. ER Squared will examine your data sources past and future; standards utilization; mapping requirements; and data consumer requirements. These are all factored into designing a solution that grows with you to provide benefit now and into the future. A key factor to our success is our rare ability to provide a bridge between business users and IT through our blend of business and technology experience.

Start reaping the value of a CDR by contacting us today.

Electronic Data Capture (EDC)

ER Squared is in a unique position to provide unparalleled EDC perspective. Our founder started his career in the Pharmaceutical industry as a data manager working with paper CRFs using a very manual intensive processing model. Recognizing opportunities to improve the process, he jumped at the opportunity, in 1985, to become involved in one of the industry’s initial deployments of the first commercial EDC system. Even in these early days EDC was successfully used for numerous trials from Clinical Pharmacology through pivotal Phase III trials. After changing companies, our founder played a key role in implementing EDC and championing the change management required to adopt EDC for 100% of trials, first domestically and then globally. This was accomplished a decade before widespread adoption of EDC in the Pharmaceutical industry. This early adoption was regarded as a competitive advantage by senior management and therefore not publicized.

Throughout this journey, we’ve gained experience in all aspects of EDC, ranging from product selection and implementation, core system development, global support provisioning, eCRF development, edit check development, standards definition, system integrations, internal hosting, external hosting, store & forward, and online web based software as a service (SAAS) solutions. Our team at ER Squared includes several members who participated in this journey and provide substantial depth to our EDC expertise. Our range of experience from the earliest days of EDC, especially our ability to successfully deploy it a decade before the rest of the industry, are testament to our ability to guide our clients in the successful adoption and deployment of EDC.

Our experience extends well beyond EDC to encompass associated topics including, but not limited to: end to end data management services, clinical trial programming, data repositories, data visualization, clinical trial management systems, clinical portfolio strategies, resourcing strategies, standardization, structured study designs, sample management, and biobanking. This wealth of experience provides insights into the broader picture to provide guidance on how EDC fits into a comprehensive system portfolio and process definition to be able to maximize the value of your investment.

Reap the value of our experience by contacting us today.

Study Design Process Optimization

Study design process optimization is often also referred to as structured study design (SSD). We feel that SSD tends to focus too narrowly on standards and technology, which is why we prefer to refer to it as study design process optimization. Clearly, the creation of a clinical trial protocol requires the coordination of activities across staff skilled in trial design, trial execution and medical writing. Trial design is the most crucial activity in the creation of a protocol, but is often overshadowed by the process of writing, reviewing and approving the document. According to the October 2011 report from the Center for the Study of Drug Development (CSDD) at Tuft’s University, a study of protocol amendments revealed that nearly one third are considered avoidable. In a follow up study conducted by CSDD, approximately 25% of clinical trial procedures were considered non-core, or not directly tied to planned trial end-points. ER Squared has experience bringing trial design to the forefront by evaluating trial design and protocol authoring processes while implementing solutions to reduce document authoring complexities. We can help you implement solutions that can significantly reduce protocol waste, unnecessary data points, and avoidable amendments.

Start improving your process by contacting us today.

Change Management

Successful implementation of a new technology is highly dependent on effective change management. ER Squared’s consultants are efficient in understanding the challenges that plague change management exercises. Over the years, ER Squared has developed an effective and successful 8-step approach to change management.

1. Align Business Goals and Organization Strategy
2. Generate Sponsorship
3. Build and Prepare the Team
4. Assess Complexity and Develop Plan
5. Manage Expectations through Targeted Communication
6. Manage Risks
7. Measure Performance and Modify Plan
8. Cultivate Growth

Through a combination of skillful change management consultants, extensive understanding of the life sciences domain and in-depth experience with drug development workflows, ER Squared is primed to collaborate with you to successfully define and implement a change management strategy to assure project success.

Contact us today to effectively manage your process, system, or organizational change.

Animal Health Data Management

Animal Health trials face greater variability than human health trials, yet there are many lessons learned from human bio-pharmaceutical solutions that can be adapted and applied to assist efficient processing of animal health trials. Having worked with both human and animal health trials, we can assist animal health companies in leveraging the lessons learned to improve data processing.

Benefit from our perspective by contacting us today.

Validation

In today’s climate it is imperative that companies initiate validation activities at the outset of any eClinical project to ensure continuity and consistency of the project’s validation strategy and documentation. Conformance to regulatory requirements imposes a significant burden to conduct and complete required validation activities. Validation activities can consume a significant portion of a project’s resources. ER Squared can provide comprehensive services to assess each stage of your project to determine appropriate validation according to a risk based assessment. Our assessments are based on patient, business and technology risk factors to manage the overall complexity and volume of validation activities.

ER Squared differentiates itself by providing auditors with real life experience from supporting both technological and operational service delivery. As such, we have experienced internal audits and external inspections by clients and regulatory authorities. With experience from both sides of the aisle, as auditees and auditors, we have the insight to not only conduct audits but to help you assess what the results mean to you.

Our services range from basic assistance with test script execution to full blown validation planning and coordination on large scale projects. ER Squared is ready to meet with you to discuss your validation needs.

Benefit from our perspective by contacting us today.

Venture Capital Investor Consultation

Investors are looking for non-biased input to assist in their investment choices. ER Squared provides perspective based on years of insider decision making responsibilities. We leverage our pharma and consulting experience to provide real world insight into the usefulness, potential impact and possible acceptance of new technologies as well as the outlook of existing technologies as they start to mature in the marketplace. We provide investors with a realistic overview of the biopharm industry, barriers to overcome, and emerging trends.

Contact us today to get the advantage of our experience.

Vendor Consultation

The sheer number of technology vendors trying to establish themselves and gain market presence in the bio-pharmaceutical industry is staggering. Just attend the annual DIA convention and you will easily see numerous vendors that you’ve never seen before. Meanwhile, the bio-pharmaceutical industry adopts new technology at a snail’s pace. Therefore, it is imperative that technology companies do significant intelligence gathering before attempting to launch another “me too” system or one for which customers may not yet realize the value proposition. ER Squared can assist companies in assessing the market potential and provide guidance on their development road-map.

Contact us today to get the advantage of our experience.


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