The importance of developing rTPP to build biotech asset value
Discover how Biotechs can build value into their asset by developing a reimbursable Target Product Profile (rTPP).
The impact of real world evidence on drug marketing approval and reimbursement
Increasing use of real world data and real world evidence for market regulatory decisions can lead to a more holistic understanding of safety and potency factors for healthcare practices.
Redefining sourcing model terminology
This blog explores the new framework for defining CRO sourcing models and explains its importance.
Optimising biotech trial designs to stretch your cash runway
Read this blog to learn a few key considerations to help optimise and de-risk your trial design.
Crafting a competitive biotech funding pitch
Biotechs can hone their pitch with the guidelines provided in this blog and through early engagement opportunities with strategic partners.
Medical device classifications and applicable Food and Drug Administration regulations
Medical device manufacturers should understand how their product is viewed by regulatory bodies to proceed with the appropriate regulatory pathway to market.
Filling the gaps for rare and orphan diseases
Read the blog to learn more about the benefits and challenges of Rare Disease natural history studies.
Pharmacovigilance outsourcing: Tips for selecting a service provider
Selecting a vendor requires careful exploration and planning to ensure a successful relationship between sponsor and outsourcing partner.
MDR transition period and certification bottleneck
It is of paramount importance that companies with expiring certification begin the process to remain compliant under the new MDR. Read more about identified challenges and solutions.
Implementing surveillance measures to prioritise patient safety
Patient centricity is a top priority at ICON. We use the latest technologies to detect and manage potential risks posed by medicinal products in accordance with GVP.
US marketing approval of drugs and devices by sole reliance on foreign (non-US) clinical data
Clinical research is becoming increasingly global. Sponsors may choose to conduct multinational clinical studies under a variety of scenarios at both foreign (non-US) sites and US sites.
Challenges and key success factors for linguistic validation and COA translation within clinical trials
This blog outlines challenges and key success factors in the linguistic validation process.
Chemistry, manufacturing, and controls in drug development and life cycle management
Chemistry, Manufacturing, and Controls (CMC) is the “first step” to ensuring drug quality throughout the product development lifecycle.
Understanding the impact of the Clinical Trial Liaison (CTL) function
The impact of the clinical trial liaison function (CTL) in developing and delivering optimal clinical trials.
Empowering children with education through clinical trials
In support of World Children’s Day 2022, this blog shares strategies to empower children every day through education, specifically in clinical trials.
A rare partnership: collaborating with patient advocacy organisations for rare disease registries
Rare disease registries: practical ways to build trust and collaboration with patient advocacy groups.
Keep eCOA off the critical path of clinical trial startup
In today’s patient-driven and competitive drug development landscape, healthcare organizations cannot succeed without active patient insight through COAs.
Managed Service Providers
Managed Service Providers ensure our businesses have competitive advantage especially in the area of language and translation services.
Scaling up to CGT commercialisation in a transitioning market
The market for cell and gene therapies (CGTs) is rapidly transitioning from ultra-niche science to approved therapies.
Best practices for Cell and Gene Therapy manufacturing, handling and delivery
Cell and Gene Therapies (CGTs) offer promising ways to treat previously devastating and intractable diseases.