Investigator-Sponsored Research

Alexion is committed to collaborating and fostering new relationships with researchers for innovative research projects that advance medical and scientific knowledge about our products, product candidates, and therapeutic areas of interest.

The global Investigator-Sponsored Research programme is open to all researchers who are interested in conducting their own research. Applications for support of observational and clinical research are accepted from individuals or groups, as either full concepts or protocols.

All proposals are reviewed by one or more cross-functional committees consisting of medical and scientific staff in order to confirm patient safety, operational feasibility, scientific merit and alignment with Alexion’s strategic research goals.

Depending on the type of research, Alexion may provide financial and/or non-financial support for approved research projects.

Click here for more information about support of pre-clinical and basic research projects involving Alexion compounds in development.

Alexion is currently accepting research proposals in the areas of:

  • Hematology
  • Metabolics
  • Transplant
  • Nephrology
  • Neurology
 

Alexion encourages communication of innovative ideas in rare diseases. Research ideas in both complement-mediated and non-complement-mediated rare diseases in other therapeutic areas are also of interest.

Researchers interested in submitting a proposal or a protocol to Alexion for consideration will first have to register on our web-based system with their profile.

Download instructions on how to
register on our web-based ISR system

Once you have registered in the system, you can submit an application electronically.

Download instructions on submitting
ISR applications to Alexion

NOTE: All submissions must be via the website. Email submissions are not accepted

Apply Online

What is an Investigator-Sponsored Research?

 

Investigator-Sponsored Research is independently-sponsored research conducted by one or more healthcare professionals or scientists who have an interest in examining the effects of a drug product in a particular setting and/or population.1 In this type of study, the healthcare/research professional assumes both legal and regulatory responsibilities and performs the role of sponsor-investigator (SI). The role of sponsor-investigator role can also be assumed by an institution. Alexion may support an ISR in the form of product and/or funding.

1International Conference on Harmonization (ICH) E6: Guideline for Good Clinical Practice

 

What information is required for an application?

 

In order for your submission to be considered complete, Alexion requires the following:

  • A completed Investigator Sponsored Research (ISR) Application
  • Investigator Curriculum Vitae (CV)
  • Requested Support (i.e., budget and/or clinical supply)
 

What is Alexion’s Review Process?

 

All ISR concepts or protocols submitted to Alexion are reviewed by one or more cross-functional committees using criteria such as (but not limited to):

  • Overall value and benefit to the scientific community (e.g., research that investigates a previously unanswered question)
  • Potential risk/benefit profile for the patient(s)/subjects(s)
  • Sponsor-Investigator’s experience and the ability to conduct and disseminate study results
  • Logistics for financial or non-financial (e.g., drug supply) support
  • Adherence to good clinical practices standards and local regulatory requirements
  • Relevance of the proposed research to overall Alexion clinical or medical strategy

Upon completion of the review, the sponsor-investigator will be notified of Alexion’s decision. Please allow approximately 3–4 months for Alexion to complete the review process.

 

What are the steps and expected timelines for ISR applications at Alexion?

 

The average review period for all applications is 3-4 months. During this time, Alexion may reach out for additional or clarifying information. Please respond to these requests as quickly as you can in order to ensure timely review of your application.

If a research idea is approved:

  • Sponsor-investigators must provide a final study protocol within 90 days of approval (if not previously supplied)
  • Contract negotiations begin at time of application approval and average 3-6 months
  • Labelling of clinical supplies (if applicable) commences once a final study protocol has been received; time to first shipment of clinical supplies is 3-4 months from receipt of final protocol
 

Please email ISR@alxn.com for inquiries related to the Alexion Investigator-Sponsored Research programme.

Note:

All research proposals must be submitted via the website. Email requests for approval of research proposals are not accepted. Additionally, feedback on research concepts will not be provided via ISR@alxn.com

Once a study is activated, any changes or updates to a study can be submitted via Alexion’s ISR system. These updates may include:

  • Study Status Update
  • IRB/EC Approval Update
  • Requests for clinical supply (if applicable)
  • Protocol Amendment
  • Publication Update
  • Other Document Update (e.g., Research Agreement, CV, Final Study Report)

Periodic Study Status Updates are required for all ongoing studies at least once every three months.

Download instructions
on submitting study updates

 

Submit Update

  • 1

    Login or Register

    (first time users only): As a first time user, you will be required to create a profile for your organization. For more information on how to Log In or Register click below.

    ISR Registration Instructions

  • 2

    Apply

    Once registered, you can submit your clinical or observational research proposal. For more information on how to apply click below.

    Submitting an ISR Application

  • 3

    Review

    Alexion will review each research proposal to confirm patient safety, operational feasibility, scientific merit and alignment with Alexion’s strategic research goals.

  • 4

    Notify

    Applicants are notified by email regarding the decision of the Investigator-Sponsored Research Committee. This information is not provided by telephone.

    Completing non-U.S. Financial Forms*

    *For applicants whose research projects are approved

  • 5

    Execute

    Alexion requires quarterly online updates for approved proposals in order to process invoices or clinical supply requests. For information on how to submit study updates or request clinical supplies click below.

    How to submit study updates

  • 6

    Reconcile

    Alexion requires receipt of a final study report and reconciliation of all clinical supplies provided in support of an investigator-sponsored research study within 90 days of study completion.