Digital Pre-Approval - Clinical Development, Regulatory and BSI

In life sciences, accelerating the journey from early-stage innovation to market registration requires a fusion of scientific rigor and digital agility. PLG’s Digital Pre-Approval services provide the expert consulting that enables that fusion for pharmaceutical, biotech and medical device developers.  

We bridge the gap between operational processes and the latest information technology, ensuring your research, clinical development, and regulatory affairs operations are fully optimised and compliant.  

As an independent, vendor-neutral advisor, PLG offers completely unbiased evaluations and strategic recommendations. Our industry-proven project methodologies ensure complex digital transformation initiatives are delivered on time, within budget and to the highest standards of quality and regulatory compliance. 

To systematically derisk and accelerate your R&D pipelines, our Digital Pre-Approval services are structured around five core pillars: 

1. Selection and Implementation of R&D Systems 

Deploying the right digital infrastructure is vital to modern clinical and regulatory success. PLG guides organisations through an objective, metric-driven vendor selection and deployment process. We compile user stories, define comprehensive system requirements and design AI ready, interconnected application architectures.  

Our extensive cross-platform experience spans the entire spectrum of life science R&D ecosystems, ensuring successful strategy, selection, implementation and GxP validation for:  

• • Clinical Trial Management Systems (CTMS) and Electronic Data Capture (EDC)  
  • Electronic Trial Master Files (eTMF) and Quality Management Systems (QMS)  
  • Regulatory Information Management Systems (RIMS) and eCTD software  
  • Statistical Computing Environments (SCE), Clinical Data Lakes and Master Data Management (MDM) platforms  
  • Virtual Trials Infrastructure, including eCOA, eDiary, eConsent and televisit tools  

2. Implementation and Support of BSI’s R&D Systems

As a preferred implementation partner for BSI Life Sciences, PLG provides end-to-end expertise for BSI’s powerful, cloud-based software suite. We lead sponsors and CROs through pre-scoping, process mapping, configuration, data migration, validation and system integration (including standard integrations with major EDC vendors and automated payment solutions).  

Post-deployment, we deliver continuous application maintenance, release management and functional support to maximise your software investment.  

3. R&D Digitalisation Strategies

True digital transformation requires a strategic roadmap. We collaborate with your leadership to construct a clinical IT strategy that aligns digital investments with operational clinical goals.  

PLG delivers detailed business cases that accurately project costs, quantify efficiency gains and map out a phased transformation timeline, ensuring your R&D architecture scales seamlessly as your pipeline grows.  

4. R&D Process Optimisation and Quality Documents Development

Imprecise or outdated operational workflows can significantly impact development cycle times. Our consultants conduct thorough As-Is/To-Be process mapping and gap analyses to eliminate silos and harmonise workflows.  

Because compliance is foundational to innovation, we provide expert advisory services to design scalable quality frameworks, write or revise robust Standard Operating Procedures (SOPs) and Work Instructions (WIs), and ensure complete alignment with GCP, GAMP 5, GDPR and international regulatory standards.  

5. R&D Application Specialists

We enhance your operational capabilities by providing targeted, event-driven expertise exactly when your projects demand it. PLG delivers scalable teams of highly certified Project Managers (including Scrum, PMP and Prince2 practitioners), Business Analysts and Clinical Application Specialists that can support your project from start to finish.  

Our specialists possess extensive, hands-on knowledge of “Ways of Working” in life sciences, handling day-to-day business administration, system upgrades, user training and data management across all core R&D applications.