r&d technology

Technology solutions for life sciences that get products to market quickly and efficiently.

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R&D Technology Consultant

R&D Technology for Life Sciences

With access to the latest technology and trends, ProPharma’s team of R&D technology consultants takes an integrated approach to determine the best fit-for-purpose technology solutions for our pharmaceutical and biotech clients. We know there is no one-size-fits-all approach when it comes to science and technology, and we customize our service offerings to deliver tailored solutions that are optimized for each client’s unique requirements.

All R&D Technology Solutions

Forward-thinking approaches to life sciences with ProPharma’s R&D Technology solutions and expertise.

 

Digital Transformation Services

Our team of experts provide independent strategic and business consulting services to enable organizations of all sizes to transform their business through better use of technology. 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.

Explore Digital Transformation Services

Research Platforms

Research platforms can take significant time and personnel resources to implement in your environment; and require time-consuming workflow development and requirements gathering. In addition, after your base implementation, your organization will continue to require upgrades, enhancements, and new configurations as your science evolves.

Leveraging an experienced vendor to lead the implementation of each new system as an augment to the existing expertise on your staff can be a beneficial approach. Outsourcing the installation of your research systems provides you with peace of mind, as an expert, with in-depth knowledge of each system, will ensure optimal system configuration for your organization’s specific requirements and use-cases.

ProPharma understands that you have an important job in getting your product to the clinic and eventually to patients. Your technology should enable you to do this more quickly and efficiently. Let our team of experts develop and deliver tailored roadmaps to help you hit your milestones.

There is a range of research systems that can store your data and provide analytics to help you make data-driven decisions about the outcomes of your study. These systems support the lifecycle of your product and are comprised of an array of technologies including:

  • Electronic Lab Notebooks (ELNs)
  • Research Data/Laboratory Data Management Systems (LIMS)
  • Document Management Systems
  • Imaging Platforms
  • Data Warehouse and Analytics
  • Data Visualization and Reporting
  • Bioinformatics & Data Science platforms
  • Machine Learning/Artificial Intelligence Platforms (ML/AI)

Independent Applications 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.

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.

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Clinical Technology Services Consulting

In addition to understanding technology, our team of experts is well-versed with FDA, European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), and Pharmaceuticals and Medical Devices Agency (PMDA) requirements. This expertise enables us to take a holistic approach and optimize your technology stack, aligning both systems and process to organizational goals, and to recommend best-of-breed systems that scale as you grow.

End-to-End Support to Bring Your Platforms In-House

We start with discovery, taking the time to document requirements that align with corporate, technological, and scientific objectives. When desired, we take an active role in system selection, leading the RFP process and scoring vendors and software according to defined selection criteria. Once a system is selected, we conduct implementation and configuration planning and delivery using Agile or Waterfall methodologies. After completing baseline configuration lock, we ensure proper validation and user acceptance testing (UAT), oversee training and change management, and release the system for production in a manner that is honed to encourage successful user adoption. In addition, we offer ongoing managed services with a particular focus on continual process improvement, maximizing new-feature enablement during upgrades and maintaining compliance through effective change control.

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Developing a Strategic Roadmap

Our team of experts can work with you to develop a strategic roadmap, looking at where your organization is today and where it needs to be in the future (typically on a 3-to-5-year time scale). We then develop heatmaps of current state, based on “people, process, and technology” and after looking at technology trends, financial factors including return on investment (ROI) and cost analysis, we craft detailed roadmaps. When appropriate, master data and data flow optimization can be incorporated into the strategic roadmap.

Veeva and Other Key Platforms

Managing the wide array of clinical systems required to govern clinical studies can be overwhelming. ProPharma’s technical experts provide guidance and oversight so you can focus on what you do best - bringing new products to market. ProPharma is an official Veeva Service Partner and supports numerous technologies such as:


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R&D Solutions Consulting Services

We help our clients plan adoption and execution strategies to maximize their technology investments.

Examples of the activities delivered as part of our strategic and business consulting services include:

  • Scientific business analysis and requirements definition
  • Workflow or project prioritization to align with technology adoption
  • Business case development for technology investment
  • Strategy and planning for systems deployment, validation, and operational transition
  • Validation IQ/OQ/PQ services, UAT, and CSV to CSA process adoption

User Requirements Analysis

User requirements are critical to support new investments in software packages or determining if your existing systems are adequate. Our experts can work with your teams to lead you through this process to optimize the most efficient use of your current systems. Well-documented requirements are the key to maximizing your software investments and minimizing costs of deployment and testing prior to end user adoption.

Platform Adoption, Implementation and Deployment

Together with your internal team, we will work to develop platform and system deployment methodologies customized to your corporate objectives. By leveraging our experience, industry best practices, and industry trends, we will create a deployment plan for incremental or phased deployments, developing internal expertise or power users, develop your operational support model, and identify the best-of-breed training and adoption models. Lastly, we will guide you through a streamlined validation practice for any of your systems that fall within regulatory guidelines to ensure compliance.

platform-adoption-implementation-deployment

Technology HealthCheck

Do you have the right platform(s) to effectively carry out your science? Curious about what new technologies are available in the market that provide new capabilities that you may not have? We will review your current platform(s) deployment and identify potential areas for improvement, based on feedback from your users and support teams. We will analyze your operational and governance structure and identify methods to increase user adoption, reduce complexity, and minimize total cost of ownership.

R&D Technology Experts

toby odenheim headshot

Toby Odenheim

Senior Vice President
R&D Technology

matt dube headshot

Matt Dube

President
R&D Technology

warren vieira headshot

Warren Vieira

Research Platforms Manager

Sarah-Giorgio-rdit

Sarah Giorgio, PMP

Lead Clinical Systems Consultant

News & Insights

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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...

Medical Information Privacy PIPL China Understanding PIPL: Compliance and Implementation Challenges

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Understanding PIPL: Compliance and Implementation Challenges

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LPPV PSMF QPPV Pharmacovigilance Achieving Success with Regulatory Intelligence in Pharmacovigilance

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Achieving Success with Regulatory Intelligence in Pharmacovigilance

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Press Releases ProPharma Announces Changes to Its Executive Leadership Team

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...

Press Releases ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology

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...

Company News Press Releases Innovation and the Black Swan Prodigy Whitepaper

January 4, 2024

Innovation and the Black Swan Prodigy Whitepaper

Check out our comprehensive whitepaper, "Innovation and the Black Swan: the Imperative of AI-enabled clinical research," for an in-depth look at how embracing AI-enabled tools and technologies is...

Press Releases Awards EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

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,...

Press Releases Awards ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

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...

Press Releases Awards ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies

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...

Infographic The Cost of Poor Project Management - ProPharma

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...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

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...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

News & Insights

Press Releases ProPharma Announces Changes to Its Executive Leadership Team

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...

Press Releases ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology

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...

Company News Press Releases Innovation and the Black Swan Prodigy Whitepaper

January 4, 2024

Innovation and the Black Swan Prodigy Whitepaper

Check out our comprehensive whitepaper, "Innovation and the Black Swan: the Imperative of AI-enabled clinical research," for an in-depth look at how embracing AI-enabled tools and technologies is...

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Press Releases Awards EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

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,...

Press Releases Awards ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

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...

Press Releases Awards ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies

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...

Previous Award Arrow Next Award Arrow
EU Regulatory Sciences EU Pharmaceutical Legislation Reform: Where Are We Now?

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...

Medical Information Privacy PIPL China Understanding PIPL: Compliance and Implementation Challenges

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...

LPPV PSMF QPPV Pharmacovigilance Achieving Success with Regulatory Intelligence in Pharmacovigilance

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...

Previous Post Arrow Next Post Arrow
Infographic The Cost of Poor Project Management - ProPharma

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...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

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...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

Previous Resource Arrow Next Resource Arrow
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Complex Needs Require Custom Solutions

ProPharma builds solutions at the intersection of innovation and flexibility. We’re here to offer a custom alternative that fits your unique needs. Standout solutions scaled to your size.