The life sciences industry faces greater pressures each year. The marketplace has increased its emphasis on innovation and market penetration, while regulators push for greater transparency, accountability, and product safety.
These challenges have forced the pharma, bio tech and med devices industries to focus on global innovation, high quality and efficacy standards, and increased product information transparency. This is done while ensuring that evolving global regulations are being achieved within the stated timeframes.
In spite of these challenges, DCG has a proven track record of working closely with our clients to achieve increased operational efficiency and effectiveness through the use of proven processes and technology solutions. DCG's management consultants have the deep industry experience needed to help your company develop and execute strategies to respond to the changes affecting the Life Sciences industry.
DCG's management consulting practice has a wide portfolio of services to support your organization's needs. Those services include the following:
Strategy Services
- Operational strategy advisory services - business and technology strategy
- Operational metric analysis & design
- Business / IT landscape & roadmap development
Process Design / Improvement / Lean Six Sigma
- Process analysis, design / redesign & implementation
- Lean six sigma maturity assessment, design & implementation
- Training & change management planning
- SOP / job-aid development
Implementation Services
- Project / program management services
- Project planning & budgeting
- Vendor / Product Evaluations & Assessments
- Full lifecycle support for package implementations and upgrades
- Vendor management
- Computerized system validation (regulatory and pharmacovigilance systems)
Based on DCG's life science industry experience and toolkits, we have been able to successfully deliver a series of client initiatives across the pharmacovigilance, regulatory and quality areas. For an overview of the most recent initiatives, please review the case study details and contact our practice lead, Michael Kruczek (mkruczek@dcgroupinc.com) if you would like additional information.
Case Studies
See how we've helped our clients achieve their goals. Contact us to discuss how we can help your business achieve a higher level of performance. To see more click on one of the Case Studies below:
Project Description
- A large Pharmaceutical company wanted to assess its existing adverse event management and reporting system and then define a global vision, goals and objectives for upgrading / replacing the existing system.
- The team was engaged to lead a product assessment and identify the appropriate solution to meet the organization’s global requirements, vision, goal and objectives. This included assessing whether the organization should replace or upgrade the existing system.
Project Approach
- Utilizing a vendor analysis scorecard, the project team was able to define the key attributes and weighted scoring to support an objective product review
- Defined use case models and key assessment attributes and then performed scripted demonstration sessions to illustrate how the product met requirements with out-of-the-box functionality
- Managed and led several project planning sessions that focused on reaching global consensus on the implementation approach, scope, resources and schedule
- The outcome of this activity led to the following key deliverables:
- Implementation plan, scope & approach
- Resource plan
- Project budget
- Business case development
- Project schedule / timeline
Project Benefits
- Assessment and selection of the solution that met the vision, goals, objectives of the global organization
- Reduction in the number of custom solutions, with the selection of add-on software products
- Definition of the project implementation budget and internal / external resources
- Development of a business case to justify the reasons and applicable cost savings that could be achieved with the implementation
Project Outcome
The team provided the client with the necessary information to decide on a course of action. This decision received executive support and the implementation phase was approved.
Project Description
- A top 10 Pharmacy Benefit Management (PBM) organization was looking to establish a new risk evaluation and mitigation strategy (REMS) data management department that would be used to support a new service line being offered to its existing clients.
- The team was engaged to conduct planning and analysis focused on creating the initial structure and design of the offering.
Project Approach
- Managed and led several planning sessions to define the service offering and its core capabilities
- Utilized additional working sessions with the core business and IT stakeholders to facilitate the requirements gathering, business process and application / architecture design activities
- Worked with the quality systems and validation teams to define the master validation plan and perform a CFR Part 11 / regulatory requirement assessment to ensure the targeted core service offering would meet the regulatory reporting requirements
- Managed the definition of the development, test and delivery timeline and project schedule for the 1st client REMS implementation
Project Benefits
- Created thorough requirements and application / architecture specifications to support the delivery / implementation of the service offering
- Developed a master validation plan that would enable the PBM organization to deploy the service offering solution to existing and future clients
Project Outcome
The team enabled the client to finalize and ready for implementation the service offering’s capabilities, requirements, application design and master validation plan. The client’s internal development, validation and project management departments were able to successfully assume ownership for the subsequent implementation phase.
Project Description
- A large Pharmaceutical company initiated a multi-million dollar, multi-year initiative to implement the web version of Aris Global's Total Safety Suite v6.4 - Adverse Event Management Drug Reporting and agXchange E2B Safety Submissions (ESM) modules. This effort was in support of a finalized discovery phase initiative.
- The team was engaged to oversee and lead the client’s implementation of the new drug safety system.
Project Approach
- Provided subject matter expertise to evaluate the existing organizational workflows and process. Through this analysis, identified and implemented process improvement opportunities
- Implemented a Program Management Office to oversee the day-to-day management of the following workstreams:
- Case processing / reporting
- System integration
- Data migration
- EDI / data transmission
- Training / change management
- Across each workstream, provided the following integration services:
- PMO / workstream project management
- Business process redesign
- Requirements definition & management
- Application architecture design
- Data modeling / mapping
- Training & change management
- Training material development
- SOP / work instruction development
- Validation planning & management
- Release planning / management
- Post go-live support
Project Benefits
- Reduction in the number of operational workarounds and inefficiencies that were experienced as a result of working in a version of the software that was no longer supported
- Achieved the organization goal of retiring / decommissioning 10% of custom code to support their global reporting users
- Implementation of the new web version of Aris Global’s Total Safety suite allowed the client to implement future releases and product fixes in alignment with the vendor’s release schedule
Project Outcome
The client successfully deployed the new web version of the Aris Global Total Safety solution within the approved budget and timeline.
Project Description
- A growing BioTech was looking to develop and deploy a custom records / content management system solution to support the regulatory NDA submission process. The supporting project missed a key delivery milestone and there was concern regarding the success of the effort.
- The team was engaged to perform a product and project assessment to understand the solution gaps, options for implementing a phased solution, and the revised project timeline / schedule.
Project Approach
- Performed a product / project assessment to understand the underlying functional gaps, issues and risks that resulted in the missed deployment date
- Using the assessment findings, a new project approach, timeline / schedule and project process / procedures were defined and rolled out to the business and IT departments. Those areas included:
- Issue management
- Change management
- Requirements management
- Release planning
- Test planning & test execution management
- Provided on-going project management and oversight of the project through the 1st solution delivery
Project Benefits
- Enhanced cross-functional coordination and planning (e.g. business, IT and the vendor)
- Repeatable release management practices, with integrated software / solution quality checkpoints before releasing the application to the business user community
- Project management dashboard reporting and controls were implemented to provide the executive management team with the right level of information to reach timely project / program decisions
Project Outcome
Using the team’s structure and recommended implementation approach, the client improved the quality of its content management solution and successfully implemented the 1st phase on-time.
Project Description
- A top 15 BioTech organization finalized a product assessment and project planning initiative. As a result of this effort, a 12 month multi-million dollar project was initiated to replace its existing Aris Global Total Safety Suite Adverse Event Management & Reporting solution with the market leading, Argus Safety 7 solution.
- The team was engaged to oversee and lead the client’s implementation of the new drug safety system.
Project Approach
- Provided subject matter expertise to evaluate the existing organizational workflows and process. Through this analysis, identified and implemented process improvement opportunities
- Provided day-to-day project management leadership for the following workstreams:
- Case processing / reporting
- System integration
- Data migration
- Validation
- Training / change management
- Across each workstream, provided the following integration services:
- PMO / workstream project management
- Business process redesign
- Requirements definition & management
- Application architecture design
- Data modeling / mapping
- Training & change management
- Training material development
- SOP / work instruction development
- Validation planning & management
- User acceptance test
- Release planning / management
- Post go-live support
Project Benefits
- Reduction in the number of operational workarounds and inefficiencies that were experienced as a result of working in a version of the software that was no longer supported
- Implemented revised adverse event (AE) business process to support the client organizational growth targets
- Supported the client with the definition of new operational roles, responsibilities and future training needs for all new hires
- Developed and delivered reusable training materials to support the future on boarding of new AE processing analyst
- Development and implementation of a mission critical application's disaster recovery plan, including site to support availability and operational recovery requirements
Project Outcome
The team provided the structure and rigor needed to enable the client’s successful deployment of the Argus Safety 7 solution within the approved budget and timeline.
Press Releases
January 28, 2015:
Data Consulting Group awarded contract: MichBio Strategic Planning Effort
MichBio has launched a statewide effort, the Michigan Bio-Industry Roadmap 2015, to develop a five-year strategic plan for growing Michigan’s biosciences industry. The initiative is being conducted in partnership with the Business Leaders for Michigan and the University Research Corridor.
Michigan’s bio-industry is at a critical point given the rapidly changing dynamics in the healthcare delivery marketplace, regulatory landscape, and global economy. For the state’s bioscience research, development, and manufacturing enterprise to have future success, a shared and executable vision is required.
Michael Kruczek, Life Sciences Practice Leader at Data Consulting Group in Detroit, serves as the project manager/facilitator.
Outreach to bio-industry stakeholders is planned in the form of interviews, focus groups, surveys. Data gathered will validate key strategic themes and areas, identify new unmet needs and growth opportunities, and help develop policy proposals for legislative action. Various workgroups have formed or will be constituted to support the Steering Committee in developing the strategic plan. The final report will include performance measures and responsible parties for delivering outcomes. Annual assessments on progress are planned as follow up.
For more details about this Planning Effort, visit the MichBio website at http://www.michbio.org/news/news.asp?id=212911
For more information about the people and organizations involved: http://www.businesswire.com/news/home/20150128006428/en/Michigan%E2%80%99s-Statewide-Bio-Industry-Strategic-Planning-Effort-Launched#.VMvN8i6UKES
September 30, 2014:
DCG Sponsors 10th Annual MichBio Expo & Conference
Data Consulting Group proudly served as a sponsor for the 10th Annual MichBio Expo & Conference, which focused on Regulating Innovation:
Advancing Access to Healthcare. The conference was held at the MotorCity Casino on September 30 through October 1, 2014 and is Michigan's
premier bioscience event which draws the largest gathering of bioscience professionals in the state. For more details about the conference,
visit the MichBio website at: http://www.michbio.org/page/ExpoHome 
.