Industry Leading R&D Performance

We’ve created a framework to help companies in the Life Sciences industry create step-change improvement in the “Business of R&D”.  We call it our Industry Leading R&D Performance (ILRDP) framework, which includes codified methods, tools and techniques. This diagnostic framework allows us to assess how to enhance the capabilities to ensure R&D can deliver R&D business management, clinical development and clinical trials as well as clinical operations at the lowest Total Cost of Ownership (TCO), highest probability of success and highest quality, ensuring safety and efficacy. It is the foundational component, underlying all of Advanced Clinical’s services, going beyond operational excellence in every area of R&D. 

The framework includes an assessment of >100 areas across the Life Sciences business of R&D and for each granular functional area.  The ILRDP Framework organizes and analyzes a company through multiple dimensions, including, but not limited to:

• leading practices from within the industry as well as, more broadly, across industry sectors
• risks and associated risk mitigation plans
• a checklist of key deliverables with associated perspective on what “good” deliverables should have in them
• complete diagnostic that results in a view of what is performing well and which areas require an opportunity for improvement
• Key Performance Indicators and Benchmarks
• And much more

Advanced Clinical first classifies the company’s different business functions under four business areas:

1. R&D Business Management:

R&D Business Management - Ensures the management of R&D activities to enhance discovery and optimize the application of new ideas to products or services. This includes areas such as R&D strategy, portfolio management, business value and performance management, translational stage management and in-licensing/out-licensing.

Discovery and Pre-Clinical - Ensures the proper identification of drug candidates, synthesis, characterization, screening and assays for therapeutic efficacy. Ensures management of feasibility studies, iterative testing and safety (GLP) data is collected to determine which drugs should proceed to clinical trials. These company functions include discovery science strategy, informatics, portfolio management, emerging science and discovery technology, target discovery and preclinical development, chemical library development and synthesis, lead identification, validation and optimization.

2. Clinical Development and Trial Management:

Clinical Development Management - Ensures that clinical trials yield results that enable a clear determination on the efficacy and safety of health interventions (e.g., drugs, diagnostics, devices, therapy protocols) in human populations. This includes clinical development plan, NDA plan and submission, drug formulation strategy and management, product identification/target product profile, product/solution lifecycle planning, project management and blueprint, risk and issues management, design and management of pharmaceuticals, mode of action studies, pharmacovigilance, clinical supply monitoring and outcomes research.

Development Management (single trial) - Ensures that a single clinical trial yields results that enable a clear determination on the efficacy and safety of health interventions (e.g., drugs, diagnostics, devices, therapy protocols) in human populations. Areas include clinical strategy, pharmacology (including biomarkers)/pharmacokinetics management, statistics, analytical and data standards strategy, protocol plan (includes CTI, e.g., Adaptive trials), data management, biostatistics analysis and reporting, drug supply management, biomarker, pharmacology, pharmacokinetics assessment and management analysis and reporting, medical writing standards, planning and execution, trial "end-game" lessons learned, experiences and results.

Trial Operations - Ensures that the trials yield data and insights that help determine the efficacy and safety of health interventions (e.g., drugs, diagnostics, devices, therapy protocols) in human populations from Phase I to Phase IV trials. This includes patient enrollment and recruiting strategy/site strategy, safety management, investigator management, drug formulation and supply management, site monitoring and auditing.

3. Common Functions:

Regulatory and Compliance - Ensures that regulatory and compliance issues associated with bringing drugs to market are managed appropriately across R&D, clinical development and trials. This includes regulatory management, safety management, SOP and quality management, legal and compliance management and IRB investigator submission, review and approval.

Resource Management - Ensures proper management, allocation and development of human capital resources across the organization. This includes HR and workforce strategy, resource performance and cultivation, culture strategy, leadership empowerment, resource and leadership decision making, training, incentives and rewards, resource and performance tracking, team integration and productivity and ramping.

IP, Knowledge and Asset Management - Ensures that IP, knowledge and assets are managed judiciously across the organization with an emphasis on protection and monetization as appropriate and defined in corporate objectives. This includes IP management, knowledge management, industry insight integration, asset management, continuous learning and maintenance.

Ecosystem and Communications Management - Ensures proper integration and communication with relevant ecosystem participants. These areas include stakeholder ecosystem strategy, communications and engagement management, industry evolution management, external partner/alliance, CRO and other supplier selection, insight capture and synthesis, and internal ecosystem management.

4. Business Management:

Business and Operations Management - Ensures that overall organization operates cohesively, efficiently and is aligned to strategic vision. This includes corporate strategy, operational excellence strategy, (including KPIs, fused process and IT strategy), finance support strategy, business performance management, process management and optimization, IT management and optimization, finance and accounting management, KPI performance tracking, contract and agreement management, account billing, paying and receiving, and IT and process optimization.

Marketing - Ensures effective management of marketing all aspects of the product and company to the respective key stakeholders consistent with corporate strategic objectives. This includes market forecast, tactical marketing, media strategy, pre-marketing value risk analysis, brand strategy, campaign management, marketing collateral development and brand promise realization.

Sales - Ensures successful sales outcomes in accordance with corporate strategic objectives. This includes channel strategy, pricing and contracting strategy, sales and account management, contact and account management, sales force management, contact touchpoints and sales execution.

CMC/Manufacturing/Distribution - Ensures effective management of product CMC, manufacturing and distribution to deliver products that meet specifications in a timely and efficient manner. Areas include CMC, manufacturing, distribution, supply management, distribution oversight, inbound/outbound logistics, wholesaler/other relationships, distribution center operations and customer service.

Advanced Clinical further groups the company’s functions, separated by business areas, into strategy, management and execution operational business levels.

Business Level:

• Strategy: Functions that deal with overall vision, direction, roadmap, initiative portfolio and plans
• Management: The organization, processes, technology, metrics and financial blueprints, as well as procedures and policies to ensure the strategy gets done
• Execution: The functions that do the work, under the constructs from the management level

Definition and Assessment:

After classifying a company’s functions by both business area and business level, they can then be individually organized using our ILRDP framework by:

• Definition
• Deliverables
• KPIs/Benchmarks
• Checklist of Key Action and Leading Practices
• Typical Risks/Mitigation
• Technology/Technology Leading Practices

From this, the assessment opportunities, along both individual functions and the whole company, are endless, including, but not limited to:

• Optimization opportunities
• Synergy opportunities
• Core/non-core/context designation
• Areas of differentiation/innovation
• Revenue generation
• Ecosystem opportunities
• Workforce strategy