R&R
LinkedBio manages the full drug development cycle from the sponsor's position. See the role it takes on at each stage.
| Stage | Item | LinkedBio R&R |
|---|---|---|
| Development Strategy | Development roadmap | Development strategy and roadmap fitted to the target and modality, designed from the sponsor's perspective |
| Pre consultation | MFDS pre consultation | |
| Market access | Market Accessibility Report | |
| Pricing | In preparation | |
| Due diligence | Data review and gap analysis of in licensing candidate assets | |
| Nonclinical | Nonclinical design | Design of nonclinical studies including toxicology and efficacy |
| CRO selection | Bidding on price, capability, financial standing and quality, with on site audit when needed | |
| Report review | Review of nonclinical reports and follow up | |
| IND | IND preparation and submission | IND strategy, document compilation and submission |
| Clinical | IND holder | Files and holds the IND in LinkedBio's name and serves as the party conducting the trial. Can also act under delegation from the clinical trial plan approval holder |
| Clinical design | Drafting and review of the clinical trial protocol | |
| Clinical operations | Selection of sites and CROs, schedule and progress management, review of CRO quotations for adequacy and response | |
| Specialist staffing | DM, statistics, medical writing, PV and EDC specialists deployed by stage | |
| KOL network | Clinical advisory and connection to investigator site KOLs | |
| Regulatory | Marketing approval | Approval strategy, document compilation and submission |
| Long term follow up | Long term follow up of advanced biologics | |
| Full cycle PM | Integrated project management | Integrated management of timeline, budget and risk from development strategy to approval, with stage by stage reporting to the sponsor |
Development Strategy
Nonclinical
IND
Clinical
Regulatory
Full cycle PM
Capabilities
LinkedBio provides a sponsor-centered execution framework connecting strategic planning, clinical execution, and regulatory readiness.
What We Deliver
Rather than fragmented functional support, we deliver integrated execution capabilities that enable sponsors to achieve real results.
1.
Clinical strategy must be executable—not just a plan. We translate indication selection, trial design, and endpoint definition into operationally concrete plans, grounding development strategy in feasibility, timelines, and risk.
2.
We do not merely administer. We co-lead the program from the sponsor’s perspective. We participate directly in decision-making, aligning CROs and vendors on a single direction so the project advances without drift.
SPONSOR TAILORED EXECUTION MODEL
We design and run strategy and execution together, tailored to the sponsor’s context and development stage.
Diagnose current project status, resources, and key risks, then align development strategy and operating direction from the sponsor’s perspective.
Design the operating structure and decision framework, clarify roles and communication flows, and establish a foundation for a stable program start.
Integrate management of timeline, budget, quality, and risk; coordinate CROs and vendors; and continuously lead the program from the sponsor side.
Analyze and improve issues arising during operations to remove latent risk before it materializes.
