Overview

transformation_service

OmniComm Professional Services provides product-independent consulting services across all aspects of clinical research.  Our experts have worked around the globe with pharmaceutical and life sciences organizations, delivering software, process and documentation solutions of the highest quality.  We have extensive knowledge in the following areas that drive the medical and life sciences professions:

  • Industry standards (e.g., CDISC, WHO, HL7)

  • Regulatory standards (e.g., ICH, 21 CFR Part 11, HIPAA, etc.)

  • New paradigms, including Quality-by-Design, Risk-Based Monitoring, and Patient-Centered research 

Our team can assist in many areas across the eClinical business, technology and compliance services spectrum.

OmniComm Professional Services will deploy project teams that bring a blend of technology expertise, clinical industry experience, standards implementation, compliance, and thought leadership.

The roadmap to pervasive clinical transformation requires recognition of operational change opportunities, the implementation of new technology innovations, along with an investment in planning, process design, SOPS, training and business deployment. Let OmniComm Professional Services help rationalize the opportunities for change, and define a high level roadmap for implementing new technologies and operational improvements.

 

Professional Services

Customizable Services and Deliverables:

Project Management

  • Project planning and management
  • SDLC methodology creation

Clinical Business Consulting

  • Business analysis and requirements gathering
  • eClinical readiness assessment and workshop
  • Data dictionary and global library design and development
  • Industry standards adoption including CDASH, SDTM, and ODM
  • EDC metrics and measurement workshop
  • Risk-Based Monitoring (RBM) - full enablement

Technology

  • Infrastructure design and capacity planning
  • Environment setup and installation
  • Integration to enable a complete solution
  • Custom software development and reporting

System Interface Consulting

  • Custom imports and exports and web service implementation
  • Data migration and transformation

Quality and Compliance

  • Process design and optimization, including SOP accelerators
  • Regulatory consulting services, including validation accelerator
  • FDA 21 CFR Part 11 compliance assessment
  • Trial validation services for data capture systems

e-Clinical Strategy

The clinical trial ecosystem is experiencing a period of revolutionary change due to cost consolidation, technology innovation, increased globalization, and evolving regulation. OmniComm Professional Services consultants can help you sort out the decision / priority tree and build a roadmap for:

  • Technology Innovation – Disruptive technologies such as mobile computing, cloud computing, EHR/EMR integration, and device integration have the ability to optimize processes, and improve data transparency. OmniComm Professional Services can help you prioritize these initiatives and develop a value proposition for each.
  • Regulatory Adoption – Evolving regulatory guidelines endorsing risk-based monitoring, central monitoring, and eSource can transform the way trials have been conducted for the past three decades. Let OmniComm Professional Services help you to choose the tools and define the processes to adopt of these new regulatory practices.
  • Operational Transformation - The roadmap to end-to-end operational transformation requires recognition of operational change opportunities, the implementation of new technology innovations, an investment in process design, SOPs, planning, training and business deployment.  OmniComm Professional Services will help you define your strategic advantage.

Clinical Business Process Optimization

  • Our OmniAdvance Methodology includes an approach for implementing process improvement and business optimization.   We will conduct an “as-is/to-be” gap analysis, and facilitate workshops that will lead to improved processes, new SOPs, increased automation, change management, training, and a clearer vision to help set your organization apart.

e-Clinical Metrics

Given the industry-wide initiatives related to operational improvement and Risk-Based Monitoring (RBM), the need to collect metrics on clinical operations, along with data quality critical.

OmniComm can work with you team to define:

  • Operational Metrics – measurements that define how an organization has performed, or how effective a process is
  • Quality Metrics – measurements that define the quality of the data entered and cleaned within a system
  • Key Performance Indicators – measurements of organizational or operational success / achievement.

e-Clinical Standards

OmniComm Professional Services has strong experience helping customers define and deploy Clinical Data Standards.

  • CDASH – OmniComm was the first to implement a library of CDISC-CDASH eCRF forms in October 2008.
  • SDTM – OmniComm was the first to deploy an SDTM mapping utility that maps EDC forms into CDISC-SDTM compliant datasets, enabling clients to generate and download current SDTM datasets on demand immediately following initial SDTM implementation.
  • Company Standards – OmniComm has worked with companies to develop corporate clinical data standards based on industry standards and therapeutic-area specific requirements or best practices.
  • E2B – Using our SafetyLink™ solution, OmniComm can transfer serious adverse event data between our EDC technology and your company’s global Pharmacovigilance solution, leveraging the ICH E2B standard.
  • MedDRA and WHODRUG – Using our proprietary Autoencoder technology, OmniComm can deliver solutions to code against MedDRA, WHODRUG, and other standard industry vocabularies.
  • caBIG – OmniComm professionals have made a commitment to provide leadership, support, and continuing contributions to the caBIG™ cancer research initiative, including development of a caDSR (cancer Data Standards Repository) metadata library, a library of forms to support the Clinical Trials Monitoring Service semantics and nomenclature, plus support for the CTCAE, CTEP simplified disease classification.

 

Download Solution Brief

e-Clinical Innovation

The opportunity to improve your operations through innovation is essential. Let OmniComm Professional Services help you prioritize your initiatives, identify some quick hits, recognize the value proposition, and create an eClinical innovation roadmap that exploits the following technologies:

  • Mobile computing
  • Cloud computing
  • eSource (EHR/EMR integration)
  • Wearable Technologies
  • Big Data/Business Intelligence
  • Social Networking

Integration and Migration

Integration

Using a variety of integration capabilities including our OmniConnect™ Web Service APIs, OmniComm has integrated a wide variety of eClinical technologies including EDC, CTMS, Safety, Portals, IRT (IVRS/IWRS), ePRO, and Clinical Data Warehouses. Our tool sets allow for both tightly coupled and loosely coupled interoperability – and our Transformation Services teams can help you design and develop the most scalable and cost-effective integration solution, to ensure that data flows seamlessly throughout your eClinical ecosystem.

Data Migration

The roadmap for migrating from one application to another does not have to be so overwhelming, if you bring knowledge, experience, and methodology to the project. OmniComm will employ our OmniAdvance™ implementation methodology, and follow a set of basic steps to ensure that your migration goes smoothly.

Our migration program is designed to lower costs, mitigate risk, ensure quality, maintain existing processes, and leverage your current investment.

Custom Reporting

While our robust eClinical software solutions offer numerous “canned” or “out-of-the-box” reports and capabilities, many customers require data representation that are customized to their specific trial, indication, or business process.

Whether you require an informal ad hoc report or listing, a formal regulatory report, data visualization or a graphic representation, an aggregation of data, or a specific patient profile, our Professional Services developers can create the explicit output or data representation to meet your unique business needs.

On-Site Support

OmniComm’s Professional Services team is available to be on site, working closely with clinical and technology teams to ensure that your organization is able to reap the full benefit of OmniComm’s innovation and business expertise. Our consultants can server as team members on a single project or across projects. We can manage entire project or programs. Also, OmniComm provides a project team to help create a new technology solution or implement an important business transformation. Our on-site team members include:

  • Technical Engagement Manager
  • eClinical Subject Matter Expert (SME)
  • Trainer
  • Compliance Expert
  • Clinical Data Analyst