R&D Technology

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.

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.

We have established experience developing customized training to support user adoption for platforms such as Benchling and can provide strategic guidance for on-going data governance and new system configurations.

Clinical Technology Consulting Services

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.

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, Medidata 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, an Accredited Medidata Partner (Dassault Systemes) and supports numerous technologies such as:

• Randomization & Trial Supply Management (RTSM)/Interactive Response Technology (IRT)
• Clinical Data Management Systems (CDMS) and Electronic Data Capture (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
• Quality Management Systems (QMS)

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.

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.