Insights blog

Clinical Supplies Management
Real World Data
28 May 2024Article
Navigating the Digital Frontier Subject:
  • Managed Access
  • ,
  • Early Access
  • ,
  • Expanded Access
  • ,
  • Patients
Clinical Supplies Management
Managed Access
28 Feb 2023Article
Rare Disease Day Subject:
  • Early Access
  • ,
  • Expanded Access
  • ,
  • Patients
Clinical Supplies Management
Managed Access
18 Oct 2022Article
Managed Access Outlook, 2023 and beyond
By Nicky Wisener VP Business Development, Managed Access
Subject:
  • Early Access
  • ,
  • Expanded Access
  • ,
  • Real World Data
Managed Access
27 Jun 2022Article
Managed access - Ex-US, understanding the regulations and key operational considerations
By Toni Williams Business Development Director
Subject:
  • Early Access
  • ,
  • Expanded Access
Managed Access
20 Jun 2022Article
Supplementing clinical development with a managed access program and post-trial access
By Dan Wasserstrom Senior Director of Global Business Development
Subject:
  • Early Access
  • ,
  • Expanded Access
Clinical Supplies Management
Clinical Supplies Management
Early Access
11 Jan 2022Article
Optimise trial supplies and post-trial patient access Subject:
  • Managed Access
  • ,
  • Clinical Supplies Management
Early Access
10 Sep 2021Article
Access to unlicensed medicines, who should pay when they are not provided for free?
By Kieron Lewis Director of Strategic Consulting
Subject:
  • Managed Access
Clinical Supplies Management
Clinical Supplies Management
Clinical Supplies Management
Clinical Supplies Management
Clinical Supplies Management
Clinical Supplies Management
27 Aug 2020Insight Blog
Clinical Supplies Management
30 Jul 2020Insight Blog
Clinical Supplies Management
Clinical Supplies Management
Clinical Supplies Management
Clinical Supplies Management
Clinical Supplies Management
Clinical Supplies Management
Supply Chain
24 Apr 2019Article
Three crucial factors to consider when sourcing comparator drugs for clinical trials Subject:
  • Strategic Sourcing
  • ,
  • Clinical Trial Services
  • ,
  • IITs
Supply Chain
04 Jan 2019Article
Cost-effective and reliable supply chain management Subject:
  • Strategic Sourcing
  • ,
  • Clinical Trial Services
  • ,
  • IITs
Patients
13 Apr 2018Insight Blog
Falsified Medicines; the Role of the Pharmacist in Raising Patient Awareness
By Mike Isles Executive Director, ASOP EU/ EAASM
Subject:
  • Patient Advocacy
Early Access
20 Dec 2017Insight Blog
Early access to orphan medicines – a glimpse into the future
By Kieron Lewis Director of Strategic Consulting
Subject:
  • Orphan Medicines
  • ,
  • Medicine Lifecycle
  • ,
  • Experimental Medicines
Early Access
01 Dec 2017Insight Blog
Early Access to Orphan Medicines: Highlights from the World Orphan Drug Congress Barcelona, 2017
By Kieron Lewis Director of Strategic Consulting
Subject:
  • Orphan Medicines
  • ,
  • Experimental Medicines
Access 101
10 Jul 2017Insight Blog
Busting 5 common myths around access to unlicensed medicines
By Rob Fox Head of Business Development – Managed Access
Policy
19 Jun 2017Insight Blog
21st Century Cures Act: Does a public expanded access policy actually mean improved access for patients?
By Romina Oxborough, PhD, MBA Director of Clinigen Consulting & Vice-President HBA UK
Early Access
02 May 2017Insight Blog
First journal to address the challenges of access to medicines
By Ivo Timmermans Chief Medical Officer, Clinigen Group
IITs
17 Feb 2017Insight Blog
Real World Data
17 Jan 2017Article
Managed Access Programmes: a powerful source of real-world insight
By Romina Oxborough, PhD, MBA Director of Clinigen Consulting & Vice-President HBA UK
Subject:
  • Access 101
  • ,
  • Patient Advocacy
Clinical Development
04 Jan 2017Article
Supplementing Clinical Development with a Managed Access Program
By Dan Wasserstrom Senior Director of Global Business Development
South Africa
13 Dec 2016Article
Accessing Medicines that aren’t available in South Africa
By Carel Bouwer (B. Pharm, M.Sc) Manager of the specialist medicine unit at Equity Pharmaceuticals
Subject:
  • Access 101
Policy
01 Dec 2016Insight Blog
21st Century Cures Act – are you ready?
By Romina Oxborough, PhD, MBA Director of Clinigen Consulting & Vice-President HBA UK
Early Access
17 Nov 2016Article
An exciting outlook for pre-approval access and compassionate use.
By Tom Watson Head of US business development
Subject:
  • Compassionate Use
  • ,
  • Expanded Access
  • ,
  • Named Patient
  • ,
  • Experimental Medicines
Compassionate Use
16 Nov 2016Insight Blog
An ethical compassionate use policy is only possible if your internal access policy is robust.
By Romina Oxborough, PhD, MBA Director of Clinigen Consulting & Vice-President HBA UK
Subject:
  • Early Access
  • ,
  • Expanded Access
  • ,
  • Named Patient
  • ,
  • Experimental Medicines
Clinical Trial Services
Real World Data
05 Oct 2016Insight Blog
Insights on Access: A welcome from Chief Medical Officer, Ivo Timmermans
By Ivo Timmermans Chief Medical Officer, Clinigen Group
Subject:
  • Early Access
Early Access
03 Oct 2016Case Studies
Providing Pre-Commercial Access Globally Subject:
  • Global Access
  • ,
  • Experimental Medicines
Medicine Lifecycle
Early Access
03 Oct 2016Case Studies
Providing Pre-Approval Access Globally Subject:
  • Experimental Medicines
Early Access
03 Oct 2016Case Studies
Addressing Pre-Approval Global Demand Subject:
  • Global Access
  • ,
  • Experimental Medicines
Medicine Shortage
03 Oct 2016Article
Successful importation of cytarabine into the United States during a critical national drug shortage
By Dee Hunnisett-Dritz Anticoagulation Pharmacist at Park Nicollet Health Services
Medicine Lifecycle
03 Oct 2016Article
Managed Access Programmes: maintaining treatment access post-trial
By Nicky Wisener VP Business Development, Managed Access
Early Access
03 Oct 2016Article
Market Access Insight: Early Patient Access
By Hema Turabee Senior program director
Subject:
  • Experimental Medicines
Early Access
03 Oct 2016Article
Making innovation count: Managed Access Programmes for medicines
By Simon Estcourt President of Managed Access Programmes
Subject:
  • Experimental Medicines
Early Access
Real World Data
01 Jul 2016Article
Real-World Evidence Gathering In The Early Access Setting
By Romina Oxborough, PhD, MBA Director of Clinigen Consulting & Vice-President HBA UK
Subject:
  • Early Access
  • ,
  • Patient Advocacy
Strategic Sourcing
27 Apr 2016White Paper
The Power Of Strategic Sourcing: It’s All About Striking The Right Balance
By Steve Glass Group Managing Director at Clinigen
Clinical Trial Services
07 Dec 2015White Paper
White paper series: Contemporary issues in comparator trial supply
By Mark Ware Head of Clinical Trial Services
Early Access
01 Oct 2015White Paper
Idis Managed Access Perspectives White Paper Subject:
  • Experimental Medicines
Compassionate Use
14 Sep 2015Article
Expanded Access: Get Ready Subject:
  • Expanded Access
  • ,
  • Named Patient
Early Access
16 Dec 2014Article
Early Access
Early Access
28 Oct 2014Article
First steps on the way to earlier access Subject:
  • Access 101
  • ,
  • Experimental Medicines
Compassionate Use
07 Oct 2014Patient Resource
Compassionate use - how to proceed Subject:
  • Expanded Access
  • ,
  • Named Patient
  • ,
  • Clinical Development
Compassionate Use
Global Access
Orphan Medicines
Early Access
31 Oct 2013Article
The pills of last resort Subject:
  • Experimental Medicines
Early Access
18 Oct 2013Article
Orphan drugs: the early access regulatory environment Subject:
  • Orphan Medicines
  • ,
  • Experimental Medicines
Experimental Medicines
09 May 2013Article
Experimental Medicines
Compassionate Use
22 Nov 2012Abstract
Compassionate Use
12 Nov 2010Abstract
Compassionate use of interventions results Subject:
  • Expanded Access
  • ,
  • Named Patient