Digital Transformation Services
Enabling organizations of all sizes to transform their business through better use of technology.
Digital Transformation Services Overview
We help companies define a digital blueprint and develop a clear, actionable plan to achieve their vision.
Whether you are just getting started on your digital transformation journey or need support with implementation/change management challenges, we are here to help. We have over 20 years of experience across the entire value chain, from early research to manufacturing, including lab systems, manufacturing systems, enterprise systems, data and systems integration, knowledge management and semantic technologies, and data analysis and visualization.
All Digital Transformation Services
Digital Roadmap
Our Digital Blueprint service delivers a robust foundation for your digital transformation journey. This established, proven methodology is designed to reduce the time required by subject matter experts and leverages our extensive experience delivering similar projects.
Through a series of structured stakeholder interviews and workshops we define:
- your current level of digital maturity
- a digital vision to support your business goals
- the digital roadmap to achieve that vision
The Digital Blueprint service includes:
- Current state assessment to understand the key systems and tools used across the business
- Business process and material/data flow mapping to identify areas for improvement
- Business requirements analysis and documentation
- Fit-Gap analysis of requirements to existing system capabilities
- Capability Landscape across the business identifying gaps and relative priorities
- Prioritized focus areas to improve the flow of data and increase data integrity, traceability, and reuse
- Key findings, risks and recommendations, including market assessment and actions
Whether you need guidance developing your digital strategy, assistance with on-going projects, or advice on post-implementation improvements – we're here to help ensure you are well equipped for your digital journey.
Digital Roadmap Resources:
- Improving the Digital Landscape at Quell Therapeutics (Case Study)
- Advanced Therapies Digital Blueprint (Case Study)
Technology Selection
We provide independent advice and support to help you choose the right technology to support your business, including:
- Business analysis and process mapping
- Defining and prioritizing user requirements
- Developing a robust, tangible business case for technology investment
- Supporting the technology and vendor selection process
Technology selection starts with documenting detailed requirements linked to business use cases. Using our proprietary database of lab informatics technologies, we compile an initial list of those candidates with the best match to the requirements and coordinate initial demonstrations. The most promising suppliers are shortlisted to proceed to a Request for Proposal and in-depth, use-case driven, workshops to identify the preferred solution. We help you develop a tangible, quantifiable Return on Investment (ROI) analysis which forms the basis of a robust business case.
Technology Selection Resources:
Data Strategy & Governance
Our Data Strategy & Governance methodology leverages our knowledge of existing industry data standards and related organizations (e.g. ISO, Allotrope, Pistoia, ISA-88 etc.) to ensure you have the best data platform to support your business.
Data governance can't just be solved by software, it requires long-term commitment and support across people, processes, and technology. Our approach involves:
- Regular, clearly defined deliverables
- Focus on business value and priority
- Adaptable to different ways of working and project methodologies
- Strong communication and guidance for business and IT
- Awareness of change, and the impact on stakeholders
We help you identify key business entities and attributes within your organization (e.g. samples and their related properties), define and agree the related data standards/terminology, implement a governance model to maintain these and select and implement software/tools to manage these.
Data Strategy & Governance Resources
- An Introduction to Scientific Data Standards
- Questions to Ask Before Implementing Data Standards in Science
- Defining and Implementing Global Data Standards & Governance
Technology Implementation & Configuration
To truly provide value, your research platforms and systems must be configured to firstly, support your organization's specific workflows, processes, and science; and secondly, to work in unison. ProPharma experts partner with you, taking the time to understand your requirements and needs, and then, in a holistic, software agnostic manner, implement the most optimal solutions accordingly. Backed with best-practice methodologies, as well as laboratory-based research experience, our team of experts will configure and implement each application your organization requires, and then ensure its optimal connection with the rest of your R&D ecosystem.
Validation, Quality & Compliance
Compliance isn't a checkbox, it’s our compass. Our experts ensure your projects align with industry standards and guidelines while keeping your unique needs and vision in sharp focus. From design to validation, we guide you through the entire lifecycle of business processes and technology solutions with emphasis on quality, compliance, and efficiency.
We specialize in seamless implementation of quality and technology solutions within the Life Science Industry. Our team have over 40 years’ experience across a wide spectrum of software solutions and hands on experience in GLP, GCP & GMP, Medical Devices, FDA, MHRA, EMA, ISO 9001, ISO 27001 and ISO 42001. With comprehensive knowledge from QMS to LIMS, ELN, SDMS, ERPs and a vast variety of laboratory instruments, equipment, and applications, we've got you covered.
We provide risk-based adaptive consulting to empower organizations to develop, test, qualify, implement, and manage technology solutions and ensure successful outcomes:
- Defining the landscape, weaving your business needs into technology and compliance recommendations, future proofing your operations
- Effective planning to ensure successful approaches to qualification, migration, archiving, quality and compliance aligned with industry standards and guidelines
- Strategic assessments enabling an adaptable and risk-based approach
- Regular methodical testing and lean approaches to ensure fit for purpose and right first time
- Develop and execute robust processes to maintain high standards of quality and compliance, ensuring smooth and efficient operations
- Inspiring and upholding a quality culture and continuously improving and maintaining quality, integrity and security
Validation, Quality & Compliance Resources
On-going Support
The evolution and maturation of your science and operations does not stop once your research platform is implemented. Ensuring continual optimization of your systems and configuration of new applications and features can place time and personnel burdens onto an organization, especially if on-staff expertise is absent. ProPharma can provide on-going management services to supplement in this context.
Meet Our Digital Transformation Services Experts
-
Eliot Randle
Senior Vice President, Digital Transformation
-
Roger Shaw
Senior Vice President, Digital Transformation
-
Dana Vanderwall
Senior Director, Digital Transformation
Eliot Randle
Roger Shaw
Dana Vanderwall
News & Insights
March 26, 2024
EU Pharmaceutical Legislation Reform: Where Are We Now?
On April 26, 2023, the European Commission proposed a new package of pharmaceutical legislation1 to revise many of the currently applicable Regulations. Background This revision is considered by many...
March 25, 2024
Understanding PIPL: Compliance and Implementation Challenges
What is PIPL? Personal Information Protection Law (PIPL) was approved in China on August 20, 2021. It was the first comprehensive data protection legislation in the region. The Law entered into...
March 25, 2024
Achieving Success with Regulatory Intelligence in Pharmacovigilance
What is Regulatory Intelligence in Pharmacovigilance? In Pharmacovigilance (PV), Regulatory Intelligence involves the collection and analysis of publicly accessible PV regulatory guidelines and...
April 18, 2024
ProPharma Now Certified as Medidata Rave EDC Accredited Partner
Leading Research Consulting Organization (RCO) Receives Medidata Accreditation for the RAVE EDC Module, Enhancing Clinical Trial Efficiency and Data Integrity for sponsors. RALEIGH, April 18, 2024 –...
April 10, 2024
ProPharma Announces Changes to Its Executive Leadership Team
Strategic Leadership Appointments to Propel Global Growth RALEIGH, April 10, 2024 – ProPharma, the leading global provider of regulatory, clinical, and compliance services for the life sciences...
January 24, 2024
ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology
RALEIGH, January 24, 2024, ProPharma Group (ProPharma), the leading global provider of regulatory, clinical, and compliance services for the life sciences industry, and a portfolio company of Odyssey...
November 27, 2023
EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist
Entrepreneur Of The Year® celebrates ambitious entrepreneurs who are building a better world. RALEIGH, NC, November 27, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...
October 11, 2023
ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023
Raleigh, NC, October 11, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...
August 15, 2023
ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies
ProPharma Recognized on the Inc. 5000 List of America’s Fastest-Growing Companies After a year of Growth and Innovation, ProPharma achieved its highest rank in 20+ year history. RALEIGH, NC, August...
June 10, 2022
The Cost of Poor Project Management
Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...
August 31, 2022
Successfully Passing MHRA Inspections for Overseas Manufacturing Sites
ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...
News & Insights
April 18, 2024
ProPharma Now Certified as Medidata Rave EDC Accredited Partner
Leading Research Consulting Organization (RCO) Receives Medidata Accreditation for the RAVE EDC Module, Enhancing Clinical Trial Efficiency and Data Integrity for sponsors. RALEIGH, April 18, 2024 –...
January 24, 2024
ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology
RALEIGH, January 24, 2024, ProPharma Group (ProPharma), the leading global provider of regulatory, clinical, and compliance services for the life sciences industry, and a portfolio company of Odyssey...
November 27, 2023
EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist
Entrepreneur Of The Year® celebrates ambitious entrepreneurs who are building a better world. RALEIGH, NC, November 27, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...
October 11, 2023
ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023
Raleigh, NC, October 11, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...
August 15, 2023
ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies
ProPharma Recognized on the Inc. 5000 List of America’s Fastest-Growing Companies After a year of Growth and Innovation, ProPharma achieved its highest rank in 20+ year history. RALEIGH, NC, August...
March 25, 2024
Understanding PIPL: Compliance and Implementation Challenges
What is PIPL? Personal Information Protection Law (PIPL) was approved in China on August 20, 2021. It was the first comprehensive data protection legislation in the region. The Law entered into...
March 25, 2024
Achieving Success with Regulatory Intelligence in Pharmacovigilance
What is Regulatory Intelligence in Pharmacovigilance? In Pharmacovigilance (PV), Regulatory Intelligence involves the collection and analysis of publicly accessible PV regulatory guidelines and...