Areas of Expertise
Our areas of consulting experience range across R&D, clinical operations, pharmacovigilance, and regulatory affairs, with +50 years of experience in our leadership group alone. We have the experience and overview that enable us to quickly understand the situation at hand and ensure business and compliance needs are met.
We are a front-runner in the SaMD field and support you by leveraging new technologies benefitting patients and employees. We help you and your team with the most current knowledge and solutions within the field of SaMDs to reach your project goal.
We support you based on concrete RBM experiences and a long track record of leveraging new technologies and solutions for the benefit of patients and employees. With the most current RBM knowledge, we ensure the best potential for your next or current RBM project.
We have a well-proven methodology for gap analysis, and combined with insights in best practices, ensures we define the right solutions for you. We support your initiatives with our in-depth experience in global PPM within the classic waterfall, agile, or hybrid methods.
With extensive knowledge in Pharma R&D processes, compliance, and security, we support your next or current RPA project – GxP or Non-GxP, attended or unattended bots. We help you reach your goals on time and ensure cross-organizational adaptation.
With extensive knowledge in Pharma R&D processes, compliance, and trial management, we support your next or current project from early analysis, requirement gathering, data and process flow mapping, solution/vendor selection, and implementation.
In collaboration with you and your organization, we outline and scope your IT strategy. We assist and guide your assessments of strategic operating models, such as CROs, technological partnerships, SaaS/cloud/on-premise considerations, and data flow for efficient processes.
We ensure transformation, engagement, and execution succeeds to support your initiative. We support your agile or digital transformation program or projects through our unique ability to combine business analysis skills with project and change management know-how.
Software as a Medical Device (SaMD)
Are you planning to introduce SaMD as a clinical and/or commercial product and are challenged finding the right approach?
We deliver hands-on trial management, SaMD development and operations, security and product quality experience, and best practice.
To many, SaMD is a new addition to the clinical business, and we recognize the importance of timely delivery aligned to trial timelines. We help ensure you and your team reach your goals with the right direction and high-quality deliverables for your next or current SaMD advancing your clinical trials. Through better alignment and engagement management, we increase the awareness of your SaMD and the adaptability to future changes while ensuring you reap the benefits.
Risk-Based Monitoring (RBM)
Do you need the ability to predict and manage the potential risk that can negatively impact your clinical trials?
We make RBM operational by ensuring consistency between the daily activities for all roles, risk profile, process, and technology.
Risk-Based Quality Monitoring (or RBM) can bring significant efficiency gains to the trial operations organization by organizing and prioritizing trial monitoring activities based on the trial (and clinical portfolio) risk profile. RBM is more than technology, and we recognize the importance of organizational and process changes primarily drive the realization of RBM’s business value. We assess how technology enables new processes, roles, and responsibilities and ensure tangible benefits through transparency and efficiency gains.
Project & Portfolio Management
Are you challenged in prioritizing your project portfolio due to resource constraints, or in need of revisiting the governance of your existing R&D project/IT portfolio?
We support you in defining your capacity and strategic objectives to help you prioritize initiatives, and we help with the implementation and optimization of your projects.
We can help you establish a framework overseeing and prioritizing your portfolio to maximize value from your business investments. We have a well-proven methodology for gap-analysis and combined with insights in best-practices we help you define solutions specific to your needs. With our in-depth experience in global Project and Portfolio Management (PPM) within classic waterfall, agile or hybrid methods, we support your planned or current PPM initiatives and help you reach your program/project milestones.
Robotic Process Automation (RPA)
Are you considering replacing time-consuming manually regulated processes with RPA or are you challenged in embedding RPA or communicating RPA purpose and benefits?
At Devote Consulting we can support your next or current Robotic Process Automation (RPA) project – GxP or Non-GxP, attended or unattended bots.
We help you in the early stages of replacing manually regulated processes with RPA by conducting risk assessments of systems and processes, as well as gathering and specify requirements related to the RPA. We support the testing and validation of your RPA and follow agile principles to ensure that all requirements are met, and all processes are included before the RPA go live. Help you manage the change that follows the embedding of RPA, through OCM (organizational change management) activities that will leverage the adoption of – and awareness about the offerings and benefits of the introduction of RPA.
Information Technology R&D (IT R&D)
Are you considering introducing a business-driven R&D IT system solution, replacing an existing one, or want to reap more benefits from an existing solution, but don’t know the best approach?
We help you identify the best-fit solution and approach and support you in addressing difficulties within the supporting processes and organization properly.
We help you identify the best-fit solution and approach, and support you in addressing difficulties within the supporting processes and organization properly. With our extensive knowledge in Pharma R&D processes, compliance, and trial-management know-how, we can support your next or current GxP IT R&D project (e.g. CTMS/EDC/eTMF/RIMS/Medical Devices). We support you from early analysis with requirement gathering, data and process flow mapping, solution/vendor selection, and implementation (pilots or big-bang) for a new solution or planning for how you can increase value from your existing tools.
Information Technology Strategy (IT Strategy)
Is your R&D organization evolving at a pace demanding investments in seamless IT services support but has significant resource and budget constraints that require strategic planning and decisions to avoid R&D business process bottlenecks?
Devote Consulting support you in planning for the road ahead regarding your IT Strategy.
In collaboration with you and your organization, we outline and scope your strategy in the areas of IT Architecture, IT R&D system landscape, clinical repositories, and data standards/storage for a scalable business with optimized trial oversight and inspection readiness. We support, assist, and guide your assessments of strategic operating models e.g. with CROs, technological partnerships, SaaS/cloud/on-premise considerations, and data-flow for efficient processes to gain the most value with fewer resources.
Agile and Digital Transformations
Are you implementing changes within your organization and meeting a reluctance to adapt and embed the new ways of working?
We support your next or current agile or digital transformation program or projects regardless of whether it is a local or organizational level.
We help you engage your stakeholders, introduce measurable KPIs for progress and reap the most benefits of your upcoming or ongoing transformation. Our ability to combine business analysis skills with project management and change management know-how ensures your digital transformation is embraced and implemented into your organization successfully.