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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.

 

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.

Speak with an Expert

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.

strategic-roadmapping

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:

  • Interactive Response Technology (IRT and RTSM)
  • Clinical Data Management Systems (CDMS and EDC)
  • Clinical Trial Management Systems (CTMS)
  • Document Management Systems
  • Regulatory Information Management Systems (RIMS)
  • Pharmacovigilance (PV) and Safety Systems
  • Electronic Trial Master File (eTMF)
  • Electronic Clinical Outcome Assessment (eCOA, ePRO, eDiary)
  • Data Warehouse and Analytics
  • Data Visualization and Reporting


Speak with an Expert

R&D Solutions Consulting

We help our clients develop a complete technology roadmap in addition to planning adoption and execution strategies to maximize their technology investments.

Our broad range of strategic and business consulting services includes:

  • Technology roadmap definition and design
  • Data strategy and governance implementation
  • Technology identification and selection
  • Scientific business analysis and workflow process mapping
  • 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

scientific-business-consult

Scientific Business Consulting

Our team of biotech and pharma domain specialists will work with your scientific, IT, and informatics teams to capture and document your operational and scientific workflows. From here, we develop the technology roadmap that is specific for your required capabilities and that supports your key programs and business objectives.

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, on the basis of 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

Sarah Giorgio, PMP

Lead Clinical Systems Consultant

News & Insights

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Congratulations to our 2015 Colleague Award Winners!

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News & Insights

Press Releases ProPharma Announces New Office Location in Medicon Village in Lund, Sweden

May 31, 2023

ProPharma Announces New Office Location in Medicon Village in Lund, Sweden

The New Office will be Located in the Ideon Science Park, the Largest Life Science Hub in Sweden. RALEIGH, NC, May 31, 2023, ProPharma Group (ProPharma), the world’s largest Research Consulting...

Press Releases ProPharma Announces the Appointment of Dr. Ronald Freeze, Ph.D., as Global Head of Medical Technology

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ProPharma Announces the Appointment of Dr. Ronald Freeze, Ph.D., as Global Head of Medical Technology

RALEIGH, NC, May 17, 2023, ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of Odyssey...

Press Releases ProPharma Announces Strategic Partnership with H1 to Optimize R&D with AI, Data Insights and Analytics

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ProPharma Announces Strategic Partnership with H1 to Optimize R&D with AI, Data Insights and Analytics

RALEIGH, NC, May 9, 2023, ProPharma Group (ProPharma), the world’s largest Research Consulting Organization (RCO) and a portfolio company of Odyssey Investment Partners, and H1, a leading healthcare...

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ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook

May 03, 2022

ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook

ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook A Customer-Centric Approach to Clinical Research Solutions ProPharma Group is honored to be named Top 10 CRO 2022 by Pharma Tech Outlook...

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ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards

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Congratulations to our 2015 Colleague Award Winners!

December 20, 2015

Congratulations to our 2015 Colleague Award Winners!

Each and every year, it continues to be a company tradition that we take a moment to recognize a select few ProPharma Group colleagues who made a special impact on our company and our clients...

Previous Award Arrow Next Award Arrow
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Jun 5, 2023 7:00:00 AM

Key Challenges of CRISPR Drug Development Project Management

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Specialty pharma companies are focused on developing drugs for niche markets, such as rare diseases, cancer, and other complex conditions. These drugs often require significant investment in research...

Previous Post Arrow Next Post Arrow
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October 14, 2021

Using Science to Achieve EMA Approval for a First-in-Class Indication

See how a scientifically-driven strategy aided regulatory interactions, leading to EMA approval for a novel oncology therapeutic. You’re developing a drug, biologic, or medical device product. Your...

Videos The True Cost of Non-Compliance - ProPharma

October 13, 2021

The True Cost of Non-Compliance

How to avoid getting your first, second, and third warning letter from a federal agency.  

Case Study When a Team Lacks Industry Experience - ProPharma

October 14, 2021

When a Team Lacks Industry Experience

Working with a team from three organizations across the globe is hard. Unifying them required experts to take the lead. Working with a team that is spread across the globe and made up of people from...

Case Study When a Team Loses Their Leader and Lacks a Plan - ProPharma

October 14, 2021

When a Team Loses Their Leader and Lacks a Plan

Projects spanning multiple functions across an organization can be difficult to execute and require the leadership of an experienced and organized project manager. But what happens if the project...

Videos ProPharma Group Overview Video  - ProPharma

October 4, 2021

ProPharma Group Overview Video

With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle.  

Flyers QP MIA Survey - Progress Self-Assessment - ProPharma

August 8, 2022

QP MIA Survey - Progress Self-Assessment

Use this readiness questionnaire to assess the current state of your progress.

Whitepapers Meeting the FDA's CAPA Expectations - ProPharma

March 21, 2022

Meeting the FDA's CAPA Expectations

Year after year, findings of insufficient corrective and preventative action (CAPA) procedures have topped the list of the most common observations found during FDA inspections within the medical...

Whitepapers What You Need to Know About Regulatory Programs for Expedited Approval - ProPharma

June 7, 2023

What You Need to Know About Regulatory Programs for Expedited Approval

Differentiating between the FDA and EMA's expedited approval pathways can be tricky. Learn the similarities and differences between them to help determine the best option(s) for your product. The...

Flyers EU IVDR Progress Self Assessment - ProPharma

February 3, 2022

EU IVDR Progress Self Assessment

The deadline for EU IVDR is May 26, 2022. Use this readiness questionnaire to assess the current state of your progress.

Flyers EMA Services: Ensure Regulatory Success - ProPharma

October 14, 2021

EMA Services: Ensure Regulatory Success

Ensure Regulatory Success Across the European Medicines Agency (EMA) and National Competent Authorities (NCAs)

Flyers Accelerating Your Product Through Drug Development - ProPharma

June 7, 2023

Accelerating Your Product Through Drug Development

Reducing Risk, Ensuring Compliance, and Accelerating Access for Patients

Flyers Cell and Gene Therapy Center of Excellence - ProPharma

October 14, 2021

Cell and Gene Therapy Center of Excellence

Accelerating Your Product Through Development: Reducing Risk Ensuring Compliance, and Accelerating Access for Patients

Flyers Data Integrity: The Quality of Your Product Depends on The Quality of Your Data - ProPharma

October 14, 2021

Data Integrity: The Quality of Your Product Depends on The Quality of Your Data

Regulatory Agencies Expect Controls to Be in Place

Flyers FDA Consulting: Regulatory Strategy Expertise - ProPharma

October 14, 2021

FDA Consulting: Regulatory Strategy Expertise

Reduce Your Time to Market With an Effective FDA Regulatory Strategy

Flyers ProPharma Group Services Overview - ProPharma

October 4, 2021

ProPharma Group Services Overview

Improving Patient Health and Safety. At Every Step.

Flyers Medical Device Development

October 4, 2021

Medical Device Development

Navigate Complex Global Requirements for Medical Device Approval

Flyers EU Market Access: Accelerate Market Access to Europe with MIA License

October 4, 2021

EU Market Access: Accelerate Market Access to Europe with MIA License

Reduce Launch Timeline and Improve Business Efficiency

Flyers Ensure Product Quality and Patient Safety With the Right Quality Management System (QMS)

June 7, 2023

Ensure Product Quality and Patient Safety With the Right Quality Management System (QMS)

Save Time and Boost your Bottom Line

eBook Outsourcing of Medical Information Content Creation: Experience of 100 Clients

October 17, 2021

Outsourcing of Medical Information Content Creation: Experience of 100 Clients

The time and effort required to write, review, edit, approve, maintain, distribute, and update Medical Information (MI) documents while retaining an auditable record of the search strategy is a great...

Whitepapers Good Science Presented Well Generates Approval

October 14, 2021

Good Science Presented Well Generates Approval

Without good data, any application has little chance of success. Working with a regulatory consultant that has an excellent understanding of the science and how to present it properly is the surest...

Whitepapers How to Compile a Science-Backed New Drug Application (NDA) Submission

October 14, 2021

How to Compile a Science-Backed New Drug Application (NDA) Submission

Developing a successful NDA is critical to the success of your product and company. Learn how to develop a science-focused submission like an expert with these six tips. You are getting ready to...

Whitepapers A Guide for Efficacious Data Integrity During COVID-19

October 14, 2021

A Guide for Efficacious Data Integrity During COVID-19

Learn how ProPharma Group implements data integrity measures to prevent reputation damage, unsafe products, and costs. With the current pandemic creating schedule delays, interrupting supply chains,...

eBook Evolving EMEA MI Service Models

October 14, 2021

Evolving EMEA MI Service Models

There are 116 countries in the EMEA region and around 24 languages spoken, how do you know what structure and model are best for each client and how do you go about making it happen? There are so...

Whitepapers What You Need to Know About GxP Independent Compliance Audits

October 13, 2021

What You Need to Know About GxP Independent Compliance Audits

Simply having the appropriate standard operating procedures (SOPs) in place is not good enough; procedures must be followed to the letter. Prevent the consequences of quality systems being...

eBook Outsourcing Medical Information Services: When to Consider a Dedicated Resource

October 4, 2021

Outsourcing Medical Information Services: When to Consider a Dedicated Resource

Outsourcing Medical Information (MI) services can be an effective solution for ensuring the provision of MI services to HCPs and consumers globally. The most cost-effective model for the provision of...

eBook Improving Product Quality During Technical Transfers

October 4, 2021

Improving Product Quality During Technical Transfers

Is your product quality at risk during a tech transfer? Now, more than ever, companies are transferring products and processes from one site to another, often facing pressures on time, resources, and...

Guide 6 Key Elements of Successful Drug & Device Development in Europe

March 31, 2023

6 Key Elements of Successful Drug & Device Development in Europe

Challenges of Complying with EMEA and Country-specific Regulations Navigating EMEA and Country-specific regulations is both confusing and a mammoth task. The EU regulatory system has around 50...

Case Study CMC Program Management Case Study

March 24, 2023

CMC Program Management

Learn how a biotech company sought help from ProPharma for the CMC section of their CAR T-cell therapy program. An experienced CMC program management consultant developed and facilitated a product...

Case Study Drug Development Program Management Case Study

March 24, 2023

Drug Development Program Management

Discover how ProPharma assisted a biotech company who needed help with drug development program management, NDA and MAA filing for their immuno-oncology products. ProPharma provided an experienced...

Case Study Medical Affairs Case Study

March 24, 2023

Medical Affairs

Explore how ProPharma helped a large pharmaceutical company who needed more medical affairs leaders for scientific and project management expertise for their rapidly growing medical affairs...

Case Study Medical Safety Scientist Case Study

March 24, 2023

Medical Safety Scientist

This case study outlines the successful collaboration between a pharmaceutical company's medical safety department and an experienced ProPharma safety scientist who was able to handle a spike in...

Case Study Quality and Analytical Scientist Case Study

March 24, 2023

Quality and Analytical Scientist

Learn how ProPharma partnered with a pharmaceutical company who experienced a spike in demand for quality and analytical scientists, necessitating the need for an experienced consultant to take...

Case Study Regulatory Affairs Project Manager Case Study

March 24, 2023

Regulatory Affairs Project Manager

The regulatory affairs department of a biotech company faced a challenge in meeting regulatory filings for important company deadlines, and sought ProPharma’s help. As a result, the client was able...

Case Study SOPs and Processing Mapping Case Study

March 24, 2023

SOPs and Processing Mapping

This case study outlines how a biotech company struggling with compliance and a lack of standard operating procedures (SOPs) turned to ProPharma for help. The consultant recommended a process mapping...

Case Study Scalable FSP Model for Managing IVD Clinical Trials in a Niche Market

March 29, 2023

Scalable FSP Model for Managing IVD Clinical Trials in a Niche Market

Scaling resources for clinical trials can be a daunting task, especially when demands fluctuate over time. In this case study, a sponsor faced several challenges related to resource allocation and...

Guide 6 Things to Consider When Selecting a Research Platform

April 6, 2023

6 Things to Consider When Selecting a Research Platform

Unlocking the Full Potential of Your Life Science Organization: Investing in Digital Initiatives As a leader in the life sciences industry, we know that data is one of the most valuable assets for...

Whitepapers Improve Quality & Consistency by Leveraging AI for Trial Master File Classification

May 3, 2023

Improve Quality & Consistency by Leveraging AI for Trial Master File Classification

Improve Quality and Consistency by Leveraging AI for Trial Master File Classification The whitepaper "Improve Quality and Consistency by Leveraging AI for Trial Master File Classification" addresses...

Guide Maximizing Patient Outcomes. A Contact Center Needs Assessment.

May 16, 2023

Maximizing Patient Outcomes. A Contact Center Needs Assessment.

Unlock the secrets to designing effective patient support programs with our invaluable guide. By embracing a patient-focused approach and utilizing our comprehensive contact center checklist, you can...

Whitepapers 5 Key Challenges in the Development of Cell & Gene Therapy

May 24, 2023

5 Key Challenges in the Development of Cell & Gene Therapy

Challenges in Cell and Gene Therapy Development Developing and bringing Cell and Gene Therapy (CAGT) products to market comes with significant challenges. This whitepaper focuses on the key obstacles...

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