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Welcome to the Animas Investigator-Initiated Study (IIS) Program

 

The Animas Investigator-Initiated Study (IIS) Program helps investigators pursue and publish original research related to diabetes. Evidence-based medicine is essential to improve the quality of life for people with diabetes. We know that today’s health care professionals and research scientists are key to tomorrow’s advances. That is why Animas has proudly supported studies around the world for many years.

 

We can help you make a contribution to medical science

The Animas IIS Program offers convenient online application and management of investigator-initiated studies. We encourage investigators to learn more about the program and apply online.

 

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About the program

The Animas Investigator-Initiated Study (IIS) Program encourages investigators to pursue and publish original diabetes-related research. Animas assists investigators by providing funds, products, or both to eligible studies.

 

How does the program work?

Investigators submit a study concept to Animas. If the concept is approved, investigators are asked to provide the study protocol and other details for additional review. Upon protocol approval, a contract is negotiated and signed. Investigators will receive funding, product, or both based on established milestones defined in the contract.

 

An IIS program study that has been supported is considered ‘completed’ once the principal investigator (PI) submits a draft abstract or manuscript suitable for publication to Animas.

 

Learn about the Animas IIS application process 

 

What is an investigator-initiated study?

An investigator-initiated study is a research effort in which the principal investigator (PI) not only designs and implements the study, but also acts as the study sponsor.

 

Although the word ‘sponsor’ is commonly used to mean any kind of support, it has a specific meaning for scientific research. The sponsor is the individual (or entity) responsible for understanding and complying with any and all regulatory requirements related to the study. Animas cannot act as the sponsor for third-party research studies.

 

As a study sponsor, the PI is responsible for:

  • Designing the protocol and conducting the scientific investigation
  • Understanding and complying with any and all pertinent laws, regulations, and guidelines
  • Understanding and complying with any and all requirements of institution(s) with which they are associated or in which research will occur
  • Reporting safety data to regulatory authorities, the IRB/IEC, and Animas
  • Registering the study on a public Web site, if applicable

 

When research is being conducted by a group of investigators, it is preferable to have one principal investigator and several sub-investigators.

 

Under the IIS program, the PI is also responsible for::

  • Disclosing business affiliations
  • Meeting applicable deadlines
  • Submitting quarterly study status updates
  • Informing Animas of key study-related milestones or events
  • Delivering a publication-quality draft manuscript upon completion of the study

 

The precise terms of Animas support and the responsibilities of the PI are detailed in the IIS agreement.

 

Download the IIS Program Guide

 

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Available support

When applying for support, investigators identify whether they are requesting funding, Animas products, or both. Animas is responsible for delivering product or funding support as detailed in the IIS agreement. Animas may also provide technical advice related to study design or selection of relevant products.

 

The Animas IIS program follows Johnson & Johnson Health Care Compliance policies designed to ensure compliance with applicable laws and regulations governing relationships between manufacturers and health care providers.

 

 

Funding

Animas may provide limited funding to cover all or a portion of any reasonable study-related costs. Funding payments are typically provided at several points during the study that are linked to study milestones.

 

Product

Animas may support investigators by providing appropriate Animas products (blood glucose meters, test strips, lancets, etc.) for use in a study. Products will either be delivered at the beginning of the study or at key study milestones, depending on research requirements.

 

Note that product availability varies from country to country. Animas will only provide products that can be legally marketed in the actual study location(s).

 

Technical support

Animas may also offer minor assistance with study design, or help investigators identify the Animas products that will best meet the needs of their research for a given patient population or the type of blood being tested.

 

Learn about the Animas IIS application process

 

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Areas of research

The Animas IIS Program is primarily interested in research in the following areas. However, Animas will consider other areas of relevant, novel research that otherwise adhere to the IIS study qualifications.

 

 

Insulin pump therapy

  • Health economic benefits
  • Clinical-related outcomes
  • Patient-reported outcomes
  • Optimization of insulin dosing
  • Studies in special patient population (e.g., patients with Cystic Fibrosis)
  • Approached to initiation of insulin pump therapy
  • Pharmacokinectic and/or Pharmacodynamic studies in pumps

 

Sensor augmented pump therapy

  • Health economic benefits
  • Clinical-related outcomes
  • Patient-reported outcomes
  • Optimization of insulin dosing
  • Accuracy-related outcomes

 

Studies related to the Artificial Pancreas Project

  • Optimizing the process of linking continuous glucose sensors and insulin pumps
  • Development of various algorithms to communicate between the continuous glucose sensors and insulin pumps

 

Algorithms

  • Innovative approaches to bolus insulin dosing calculations

 

Education and behavioral factors

  • Evaluation of the fear of hypoglycemia when using insulin in patients and caregivers
  • Selecting candidates for pump therapy
  • Family dynamics

 

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Study qualifications

 

Applications for Animas IIS support undergo extensive assessment and team review (clinical, medical, and technical) at both the concept and protocol stage.

 

The following criteria are important factors for assessing proposed studies:

  • Originality of research
  • Scientific and statistical soundness
  • Safety and welfare of the subjects
  • Impact on clinical and commercial strategies
  • Impact on intellectual property portfolio
  • Consideration of good clinical practices (GCP)
  • Consistency with governmental and corporate health care compliance directives

 

Animas generally does not provide support for studies:

  • In which the primary study objective is intended to support a registration effort, labeling changes, or other regulatory action
  • That are primarily supported by another company (e.g., pharmaceutical or competitor)

 

Learn about the Animas IIS application process

 

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Applying for support

 

The total length of time from application to contract approval ranges from two months to eight months, depending on a number of factors.

 

Step 1. Submit your study concept

You will be asked to provide Animas with basic information about the investigator(s), the institution, the study objectives, budget, curriculum vitae (CV) for the principal investigators, and other relevant details.

 

An Animas committee with clinical and technical expertise will review your request. The concept review takes between four to six weeks. If your study request receives preliminary approval, Animas will request additional documentation. If your request is not approved, you will be notified by e-mail.

 

Step 2. Submit your protocol and budget

If your study concept is approved, you will be asked to submit a complete protocol and budget, an informed consent template (if applicable), and other study details.

 

An Animas committee with clinical and technical expertise will review your request. Animas will complete this review within four to six weeks. You will be notified whether your application has been approved or declined by e-mail.

 

Step 3. Review and sign the IIS Agreement

If the protocol and budget of your project are approved, Animas will take up to eight weeks to generate an IIS agreement. You will be sent the draft IIS agreement for review and approval by you and your institution. It is not uncommon for the contract review and approval process to last between four to six months. When the terms have been accepted by all parties and the documents have been signed, you will begin to receive funding, product, or both from Animas as specified in the agreement.

 

Download the Animas IIS Program Guide

Apply Now

 

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Answers to common questions

 

How long does the application process take?

The total length of time from application to contract approval ranges from two months to eight months, depending on a number of factors.

 

When will I receive funding or product(s)?

Once a contract is signed, Animas distributes funds, product(s) support, or both to the investigators, based on the payment and study milestones established in the agreement. Products are typically distributed in advance of the study, and funds are typically distributed at milestones throughout the study, with a final payment upon delivery of a draft abstract or manuscript.

 

Am I required to apply online?

Investigators must submit applications online (using Visiontracker™, a Web-based IIS management tool).

  

How will Animas contact me?

In most instances, Animas will contact investigators by e-mail. If Animas has questions about your request or materials, you may also be contacted by telephone.

 

May I reapply if Animas does not offer to support my study?

If your application for support is not accepted, you may not reapply with the same study concept. Denial of a support application does not mean that the proposed research lacks value. However, Animas encourages investigators to pursue other sources of funding and welcomes investigators to apply again with other study concepts.

 

Will animas support studies outside the United States?

Yes. Animas provides support through the IIS program in many countries around the world. Note that product availability varies from country to country. Animas will only provide products that can be legally marketed in the actual study location(s).

 

Download the Animas IIS Program Guide

Apply Now

 

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Apply now

 

Before applying, you should know...

How the Animas IIS Program works

Study qualifications

Application process

 

Tips for success

  • Submit all materials in English
  • Organize study information and materials
  • Use clear and straightforward language
  • Respond to requests from Animas in a timely fashion
  • Demonstrate that investigators follow good clinical practice (GCP)

 

Submit an application

Apply for support online using Visiontracker, a Web-based IIS management tool.

 

Apply online

 

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Managing your study

 

For your convenience, Animas provides a Web-based application to enable you to track the status of your application, manage milestones, and update other study information. You may use the online system to:

  • Provide quarterly study status updates
  • Provide estimated dates for key study milestones
  • Report actual dates of key milestones
  • Update publication plans
  • Maintain the contact information of key study and administrative personnel
  • Inform Animas of serious adverse events
  • Deliver a draft manuscript at the completion of the study

 

Manage Your Application/Study (using Visiontracker™)

 

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Resources for investigators

 

For your convenience, these Web sites provide information related to clinical study implementation and management:

 

FDA (http://www.fda.gov/oc/gcp/) The US Food and Drug Administration provides a comprehensive site containing information related to good clinical practice in FDA-regulated clinical trials.

 

NIH Clinical Trials (http://www.clinicaltrials.gov/) The US National Instititutes of Health provides a registry of federally and privately supported clinical trials conducted in the US and around the world.

 

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AN10-553B 

 

> Important Safety Information