Saxagliptin Independent Investigators

Bristol-Myers Squibb and AstraZeneca have joined together in an equally shared commitment to support Independent Investigator Research. Bristol-Myers Squibb and AstraZeneca strive to be industry innovators in supporting and enabling Investigator Sponsored Research (ISRs)/Investigator Sponsored Studies (ISSs) that enhance patient care and meet our collective standards of quality and compliance. We value integrity, ethical conduct, and full compliance with the laws, regulations, and guidelines that govern the health care community.

We seek to provide an efficient and effective ISR/ISS application process that enables investigators to submit their ISR/ISS applications via this website. This page provides the Terms and Conditions for ISR/ISS applications and the links to each respective application. While applications will be submitted via the Bristol-Myers Squibb website, both Bristol-Myers Squibb and AstraZeneca will have access to the information submitted.

           

Terms and Conditions

Bristol-Myers Squibb and AstraZeneca have programs to support investigator-sponsored research/investigator-sponsored-studies. Qualified scientists and physicians affiliated with academic medical centers; community health centers; cooperative groups; hospitals; physician networks; private practices; and universities are eligible to apply.

  • Rationale. The trial or study must address a legitimate medical or scientific question affecting the use of a Bristol-Myers Squibb and AstraZeneca drug and not duplicate other planned or conducted research unless justified on a scientific or medical basis.
  • Sponsor. The applicant (investigator, cooperative group, institution, network) must be qualified and capable of conducting the proposed study in compliance with ICH/Good Clinical Practice (http://www.ich.org/LOB/media/MEDIA482.pdf, U.S. Food & Drug Administrations Good Clinical Practices, http://www.emea.europa.eu/pdfs/human/ich/013595en.pdf) . The sponsor must comply with all applicable legal and regulatory requirements and must not be the subject of any legal or regulatory restrictions or sanctions.
  • Medical appropriateness of proposed research. The proposed research must be reasonably likely to produce results that could beneficially impact medical therapy for the condition being investigated.
  • Scientific validity. The proposed study procedures must fulfill the stated objectives of the study.
  • Ethical considerations. The study must be designed to meet ethical guidelines concerning human subjects in research (for interventional research) according to the Declaration of Helsinki.
  • Financial support. Funding requests must reasonably reflect the cost and effort involved and should not be used to defray normal operating expenses of the sponsor-investigator or institution that are not directly related to the supported research. An executed research agreement must be in place prior to any study commencing
  • All applicable regulatory requirements, including but not limited to study registration and results disclosure, must be observed.
  • Publication of study results. The results of the research will be collected and analyzed and a report of the study will be prepared and planned for potential publication in a peer-reviewed journal.
  • Priority. We consider requests for clinical research trials in all clinical and therapeutic areas, and for saxagliptin, we give priority to proposals in cardiovascular and metabolics.

All support for investigator-sponsored research/studies is awarded at the sole discretion of Bristol-Myers Squibb and AstraZeneca based on the criteria set forth above.

Before starting the submission process, please be sure to have the following information available.

  • Contact information (valid e-mail address required)
  • Curriculum vitae
  • Budget
  • Hypothesis/Rationale
  • Objective/Endpoint
  • Treatment
  • Sample size
  • Eligibility
  • Statistical plan
  • References

Privacy Disclaimer

The information requested and filled in the submission form below will be used and processed in the US by Bristol-Myers Squib Company (BMS) and AstraZeneca UK Limited (AZ) in order to review and manage your IST/ISS submission.

The information will be treated confidentially and only accessed by authorized BMS, AZ and their affiliates personnel in Europe (including agents, contractors or consultants).

Individuals have a right of access to and verification of their personal information collected and maintained within the IST/ISS online submission as well as a right to object to the processing of their personal data, by contacting “insert contact us email address”.

Nevertheless, in case of objection, individuals may not be able to participate in the particular activity that requires the information.

All personnel whose personal data are filled in this submission form must be in agreement with the above privacy disclaimer. Therefore, before filling in information on another person, you must have collected her or his individual permission while cascading the above privacy disclaimer.

By beginning a new application, I acknowledge that I understand and consent with the above terms and conditions

Click here to agree and return to a saved application.

If you do not have your own LOI template, please utilize the template here.

For Investigator-Sponsored Research questions, please click here.