PHARMA R&D
Driving innovation, efficiency, and compliance
We understand clinical trials in all life-cycle stages from planning to submission, and we execute digital transformation changes with excellence to accelerate your R&D value chain. For us, understanding the business, people, processes and data in a regulated life science company is crucial to lead successful changes and realizing the benefits of your pipeline investments.
Keep up with THE Constant Change in PHARMA R&D
In today’s pharmaceutical landscape, the race to bring innovative therapies to market is more intense than ever. As a leader in R&D, you are responsible for not only scientific breakthroughs but also ensuring your operations are agile, compliant, and capable of delivering results on time and within budget. At Devote Consulting, we support R&D organizations define strategies and implement solutions that accelerate the development pipeline, improve decision-making, and optimize operational performance across the board.
Unlock the full potential of your Pharma R&D projects with our expertise in GxP compliance across laboratory, clinical operations, safety, and regulatory affairs. We bring the team to execute your projects effectively together with your team or solely if preferred.
WE UNDERSTAND THE CHALLENGES OF THE
PHARMACEUTICAL VALUE CHAIN
From early-stage research through clinical trials and regulatory submissions, our deep industry expertise helps you overcome the most pressing challenges facing R&D leaders today. We understand that every decision, from trial design to technology investment, can significantly impact timelines, costs, and outcomes.
ACCELERATING PIPELINE PROGRESS
We help streamline your drug development processes, enabling faster transitions from discovery to clinical trials. Whether you're refining your compound portfolio or pushing a candidate towards first-in-human studies, we ensure your teams have the insights and tools they need to make data-driven decisions.
OPTIMIZING CLINICAL TRIALS
Running clinical trials is complex and resource-intensive. We support you with implementing processes and solutions that accelerate trial initiation, enhance participant recruitment and retention, and introduce risk-based monitoring strategies to keep trials on track and reduce operational risks.
Enhancing Efficiency with Technology
Digital transformation is reshaping pharma R&D, but choosing and implementing the right technologies is crucial. We guide you through selecting and integrating digital systems that streamline data management, clinical operations, and trial reporting, ensuring your investments align with long-term goals.
Accelerating Time to Market
We streamline regulatory processes, and can guide you through compliance requirements to eliminate bottlenecks and delays. Our approach optimizes submission timelines, helping you bring new therapies to market faster while maintaining the highest standards of quality and compliance.
WE ARE A TRUSTED ADVISOR FOR PHARMA COMPANIES OF ALL SIZES INCL. BIG PHARMA
From early-stage research through clinical trials and regulatory submissions, our deep industry expertise helps you overcome the most pressing challenges facing R&D leaders today. We understand that every decision, from trial design to technology investment, can significantly impact timelines, costs, and outcomes.
WE BECOME PART OF YOUR PROJECT TEAM
AND GET YOUR PROJECT OFF THE GROUND AND OVER THE FINISH LINE
REGULATIONS & HEALTH AUTHORITIES
eCLINICAL TECHNOLOGY SELECTION & IMPLEMENTATION
GxP SYSTEM VALIDATION
SUCCEEDING WITH CHANGE & TRANSFORMATIONS
PROCESS & DIGITAL OPTIMIZATIONS - SPONSORS
PROCESS & DIGITAL OPTIMIZATIONS - INVESTIGATOR SITES
Get in Touch
We’re here to help you implement the processes and solutions you need to adapt and succeed. Get in touch with us to identify how we can support your initiative whether you need specific know-how and resource or if you need a full team to drive your project.
HOW WE CAN HELP YOU SUCCEED
UNLOCK THE FULL POTENTIAL OF YOUR R&D OPERATIONS
DO YOU HAVE A CLEAR eCLINICAL STRATEGY & ROADMAP?
As clinical trials grow more complex, meeting pipeline demands and managing new data sources requires a clear eClinical strategy. Without an aligned roadmap, your systems and processes can fall behind, causing inefficiencies and delays. We help design an eClinical strategy that aligns your clinical goals with regulatory requirements and technological advancements, ensuring scalability, compliance, and real-time data access. Whether you need support with data management, site operations, or submissions, we identify the systems (EDC, CTMS, eCOA, ePRO, RBM, etc.), capabilities and/or integrations needed to streamline operations and meet your pipeline’s evolving needs.
IS YOUR ORGANIZATION READY TO ADAPT AND THRIVE THROUGH CHANGE?
Implementing changes – whether a new system, process, or methodology – can be disruptive if not managed effectively. Many organizations struggle to get buy-in from their teams, leading to resistance and poor adoption of new tools or processes. We design and execute OCM strategies that drive successful transformation in your R&D operations. From stakeholder engagement and communications planning to impact analysis and post-launch support, we ensure that your teams embrace change. Our expertise extends to guiding transitions to new digital tools, such as CTMS or LMS platforms, to enhance your efficiency.
ARE YOUR R&D PROCESSES OPTIMIZED FOR MAXIMUM EFFICIENCY?
Inefficient or outdated procedures can slow down your R&D processes, introduce compliance risks, and hinder collaboration across departments. Many organizations struggle to maintain an optimized SOP landscape that scales with their needs. We help redesign and optimize your SOP landscape to ensure streamlined processes, regulatory compliance, and operational efficiency. Our team works to eliminate redundancies, ensure GxP compliance, and simplify approvals – All the way from draft to effective state!
IS YOUR TRAINING TRANSFORMED FOR MODERN LEARNING?
As organizations grow, training initiatives can become fragmented and inefficient. Centralizing training development and refining your strategy is essential for ensuring consistent, regulatory-compliant training across your teams. We help you centralize and transform your training strategy, creating a more cohesive and efficient training landscape. Our approach includes setting up centralized content development, automating compliance tracking, and rolling out scalable LMS solutions. Whether it’s onboarding new team members or ensuring continuous GxP training, we equip you with the right tools and strategy for sustained success.
DO YOU NEED HELP WITH GxP SYSTEM SELECTION & IMPLEMENTATION?
Selecting the right GxP system can be daunting, with numerous vendors and complex regulatory requirements to consider. Many organizations face delays or compliance issues when the wrong system is implemented or is not fully validated. We support you in selecting and implementing a fit-for-purpose system that align with your business requirements and ensure compliance from day one. From vendor selection (RfI/RfP processes) to system validation and training, we manage the entire lifecycle of GxP system deployment.
STRUGGLING TO IMPLEMENT A NEW PROJECT METHODOLOGY IN R&D?
Transitioning to new project management methodologies like SAFe®, Agile or Scrum in an R&D setting can be complex, particularly when dealing with highly regulated environments. Many organizations face resistance or struggle with proper execution during these transitions. We guide you through the process of implementing a new project management methodology that fits your R&D operations. Whether adopting SAFe, Agile, or hybrid methodologies, we ensure that your teams are fully equipped to execute projects efficiently. We also supports the parallel implementation of supporting tools like project portfolio management systems and resource planning tools to maximize success.
Get in Touch
We’re here to help you implement the processes and solutions you need to grow and succeed. We bring the team to execute your projects effectively together with your team or solely if preferred. By leveraging our deep understanding of R&D data and eClinical processes and solutions, we drive your projects forward and maximize their benefits.