Expertise for your initiative

Our areas of consulting experience range across R&D, clinical operations, pharmacovigilance and regulatory affairs, with +50 years of experience in the oi720 leadership group alone. We have the experience and overview that enable us to quickly understand the situation and ensure that business and compliance needs are met.

Are you planning to introduce SaMD as a clinical product and are challenged finding the right approach?

We can help you with direction and high quality SaMD deliverables

With our extensive knowledge in SaMDs development and clinical IT system implementation and operations, and our understanding of compliance, security and hands-on trial management, we can support your next or current SaMD that leverages your clinical trials. We offer support with program management, risk assessments, requirement gathering and testing, validation approach (release and software changes), trial management and configuration management.

Do you need better insights to individual studies or across studies and improve the output from your monitoring efforts?

We can help you understand how to get started with RBM RACT without ”a big bang project”

With our extensive knowledge on Pharma R&D processes, compliance and trial-management know-how, we can support your next or current risk-based monitoring project whether you are looking to implement centralized monitoring as a primary strategy or simply reduce efforts of source data verification (SDV). With a data and process centric approach, we can support with scoping your phases for introducing risk-based monitoring by balancing the strategies of statistical, centralized, remote, reduced and triggered monitoring and support the process implementation for increased data quality and control.

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 can help you reach your program/project milestones

With our in-depth experience in global Project and Portfolio Management (PPM) within classic waterfall, agile or hybrid methods, we can support your planned or current PPM initiatives. It can be to define a methodology tailored to your organization, create or update your project handbook, toolkits and templates as well assist in implementation of a PPM tool or utilize the value from your existing tool(s). We have a well-proven methodology for gap-analysis and combined with insights in best-practices we can help you define solutions specific to your needs. We can help you establish a framework overseeing and prioritizing your portfolio to maximize value from your business investments.

Are you considering replacing time-consuming manually regulated processes with RPA or are you challenged in embedding RPA or communicating RPA purpose and benefits?

With our extensive knowledge in Pharma R&D processes, understanding of compliance and security, and profound drive for working smarter, we can support your next or current Robotic Process Automation (RPA) project – GxP or Non-GxP, attended or unattended bots. We can support your initiative with system and process risk assessments, requirement gathering and testing, validation approach in an agile delivery setting, organizational change management, cross-functional RPA roadmap development etc.

Are you considering introducing a business-driven R&D IT solution, replacing an existing one or want to reap more benefits from an existing solution, and don’t know which approach is best?

We can 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 can support you from early analysis, 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. When collaborating with oi720, a customer-centric approach is applied securing a fit-for-purpose solution and high user adoption from initial release.

Is your R&D organization evolving with a pace that demands investments in seamless IT services support, but has significant resource and budget constraints that requires strategic planning and decisions to avoid R&D business process bottlenecks?

oi720 can support you in planning for the road ahead in regards to your IT Strategy. In collaboration with you and your organization, we can 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 can 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.

Is your organization going through a substantial transformation of how you work, but are experiencing bottlenecks in embedding new ways of working or reluctance within the organization?

We can help you engage your stakeholders, introduce measurable KPIs for progress and reap the most benefits of your upcoming or ongoing transformation

With our unique ability to combine business analysis skills with project management and change management know-how, we can support your next or current agile or digital transformation program or projects regardless of it being at a local or organizational level. We can support your initiative with leading the transformation (via best-practices as SAFe), stakeholder engagement and OCM planning/execution, scoping, roadmap development for data flows and IT solutions, as-is and to-be process mapping and gap-analysis etc.

Process
Analysis
Project
Scoping
PROCESS IMPROVEMENT
Agile Project
Management
Business NEeds Translated
Validation of Non-Standard Solutions

Consultancy for life science

oi720 offers consulting services from early analysis throughout the project life cycle and applies a 720 degree view on every deliverable. By challenging status quo and creatively combining processes, data and systems, we realize business objectives without compromising compliance.

oi720 sees Business Analysis  as the center acumen in making projects a success fit-for-business-purposes and all of our consultants apply this skill set in their role no matter their position on the project. We use agile methodologies and integrate OCM and business analysis because it engages stakeholders and delivers benefits faster than traditional methods.

Our process understanding and data- and process-centric approach is a unique trade of oi720 consultants and we strive to make a difference for our clients every day. We believe that business processes and data are the key benefit drivers with technology as an enabler. We can support your initiative if in need of consultants with a unique ability to visualize and optimize processes in collaboration with your Subject Matter Experts with an end-to-end process focus.

Our ability to bridge data, business process analysis and IT delivery improvements is a unique trade of oi720 consultants and we strive to make a difference for our clients IT implementation projects. We can support your initiative if in need of consultants that understand translating business requirements, ensuring compliance and security from early requirement gathering, risk assessments, validation planning, testing, reporting, system administration and staying in control.

oi720 sees Organizational Change Management (OCM) as an essential necessity for making your projects a success. We always apply a customer-centric mindset and assure the organization can be prepared for the change using tangible deliverables. We can support your initiative if in need of consultants that understand merging project management and business analysis with OCM

We create value through successful support of our clients improvement initiatives, and the right level of project management and stakeholder management is key to ensure timely delivery. We can support your initiative if in need of project managers, scrum masters or program managers that understand merging resource management, stakeholder management and OCM for a successful project execution regardless of the delivery approach being agile or waterfall.

Several solutions and approaches exist for any business need regardless of it being related to systems, data flow, processes or a combination. oi720 sees the practice of performing a Scenario Analysis  as an essential necessity in many cases to identify the best-fit approach and scoping your project. We can apply a scenario analysis method with a proven track-record to assure your project is set up for successful decision-making prior to larger investments being made.

Ensuring a common direction is crucial for any organization and program when major transformations are to be set up for success. We can support your initiative if in need of scoping a roadmap for your next initiative within process optimizations, digitalization and IT transformations as we understand how to merge business analysis and OCM in the context of compliance and business continuity, and the results will be an actionable roadmap with tangible next steps.

Contact us for more information

We are looking forward to hearing from you about your initiatives
and how oi720 can support in setting these up for success