This policy outlines key guidelines for commercial colleagues concerning clinical trials, interactions with investigators, clinical publications, and Health Economics and Outcomes Research (HEOR). Commercial colleagues are not to participate in decision-making processes related to these areas. For detailed policy information on research protocols, investigator selection, contracting, documentation, and disclosure requirements, please consult R&D Compliance.
This policy outlines key guidelines for commercial colleagues concerning clinical trials, interactions with investigators, clinical publications, and Health Economics and Outcomes Research (HEOR). Commercial colleagues are not to participate in decision-making processes related to these areas. For detailed policy information on research protocols, investigator selection, contracting, documentation, and disclosure requirements, please consult R&D Compliance.
Commercial colleagues must not participate in funding decisions for IITs or the selection of investigators for any Bausch + Lomb-Sponsored Trial. Specifically, commercial colleagues are prohibited from:
Additionally, conversations with customers about IITs or Bausch + Lomb-Sponsored Trials should not take place during commercial contract negotiations.
Commercial colleagues must not participate in funding decisions for IITs or the selection of investigators for any Bausch + Lomb-Sponsored Trial. Specifically, commercial colleagues are prohibited from:
Additionally, conversations with customers about IITs or Bausch + Lomb-Sponsored Trials should not take place during commercial contract negotiations.
Bausch + Lomb contracts with healthcare institutions (HCIs) and/or HCPs to obtain important information related to research and development, clinical trials, and associated activities. Interactions with investigators conducting clinical research are governed by the same legal and industry standards that apply to all interactions with HCPs.
Bausch + Lomb contracts with healthcare institutions (HCIs) and/or HCPs to obtain important information related to research and development, clinical trials, and associated activities. Interactions with investigators conducting clinical research are governed by the same legal and industry standards that apply to all interactions with HCPs.
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Commercial colleagues may not plan or attend meals with clinical investigators.
All prospective investigators must possess the appropriate experience and training necessary to conduct and oversee clinical trial activities. Investigator selection should never be influenced by a desire to boost referrals, purchases, or recommendations of Bausch + Lomb products. Commercial colleagues are prohibited from making, influencing, or discussing investigator selections.
Communications with potential investigators should be limited to responding to questions or providing guidance on how to submit a Trial Request to Bausch + Lomb. Commercial colleagues must avoid giving the impression—internally or externally—that they have any influence over the selection process.
Only Clinical Operations is authorized to engage healthcare professionals to serve as clinical trial investigators for Phase I through IIIB drug studies and device studies intended to support premarket device submissions. Decisions regarding research funding must remain separate from any marketing or sales activities.
Commercial colleagues and other employees and agents involved in direct promotion may not participate in investigator meetings.
The responsibility for determining funding and selecting healthcare professionals (HCPs) for Phase IV, other post-market studies, and Investigator-Initiated Trials lies exclusively with Medical Affairs.
All prospective investigators must possess the appropriate experience and training necessary to conduct and oversee clinical trial activities. Investigator selection should never be influenced by a desire to boost referrals, purchases, or recommendations of Bausch + Lomb products. Commercial colleagues are prohibited from making, influencing, or discussing investigator selections.
Communications with potential investigators should be limited to responding to questions or providing guidance on how to submit a Trial Request to Bausch + Lomb. Commercial colleagues must avoid giving the impression—internally or externally—that they have any influence over the selection process.
Only Clinical Operations is authorized to engage healthcare professionals to serve as clinical trial investigators for Phase I through IIIB drug studies and device studies intended to support premarket device submissions. Decisions regarding research funding must remain separate from any marketing or sales activities.
Commercial colleagues and other employees and agents involved in direct promotion may not participate in investigator meetings.
The responsibility for determining funding and selecting healthcare professionals (HCPs) for Phase IV, other post-market studies, and Investigator-Initiated Trials lies exclusively with Medical Affairs.
R&D, including Medical Affairs, is responsible for the oversight, management, and budget allocation of all Bausch + Lomb study publications, encompassing R&D trials, Investigator-Initiated Trials (IITs), and other studies. Commercial employees and agents are not permitted to participate in the creation or approval of any publications, including posters or presentations for congresses.
R&D, including Medical Affairs, is responsible for the oversight, management, and budget allocation of all Bausch + Lomb study publications, encompassing R&D trials, Investigator-Initiated Trials (IITs), and other studies. Commercial employees and agents are not permitted to participate in the creation or approval of any publications, including posters or presentations for congresses.
All uses of health outcomes research findings in promotional or educational activities must be reviewed and approved by HEOR to ensure accuracy in both reporting and interpretation. Improper conduct of outcomes research may lead to misinterpretation as promotional material, so every project should undergo the appropriate review processes. Health outcomes research must be objective, unbiased, and accurately reflect the current state of scientific knowledge using industry-accepted statistical methods. It should never be intentionally designed to promote Bausch + Lomb products.
HEOR colleagues may participate in internal discussions with commercial teams to ensure a clear medical understanding of business goals and to align medical strategies appropriately. While other Bausch + Lomb Colleagues may be invited to offer input on the design of health outcomes research, HEOR retains full responsibility for the final research design.
HEOR activities can include the development of metrics, evaluation of technical and scientific feasibility, customer engagement, as well as implementation and post-implementation assessments.
Clinical and scientific experts involved will be selected following Bausch + Lomb’s established procedures for Consultant selection. The company’s policies on Consultant Arrangements also apply. For more information, please refer to the Service Arrangements section in this Guide. Commercial colleagues may suggest specific experts for consideration; however, the final decision on expert selection for health outcomes research rests solely with HEOR.
All uses of health outcomes research findings in promotional or educational activities must be reviewed and approved by HEOR to ensure accuracy in both reporting and interpretation. Improper conduct of outcomes research may lead to misinterpretation as promotional material, so every project should undergo the appropriate review processes. Health outcomes research must be objective, unbiased, and accurately reflect the current state of scientific knowledge using industry-accepted statistical methods. It should never be intentionally designed to promote Bausch + Lomb products.
HEOR colleagues may participate in internal discussions with commercial teams to ensure a clear medical understanding of business goals and to align medical strategies appropriately. While other Bausch + Lomb Colleagues may be invited to offer input on the design of health outcomes research, HEOR retains full responsibility for the final research design.
HEOR activities can include the development of metrics, evaluation of technical and scientific feasibility, customer engagement, as well as implementation and post-implementation assessments.
Clinical and scientific experts involved will be selected following Bausch + Lomb’s established procedures for Consultant selection. The company’s policies on Consultant Arrangements also apply. For more information, please refer to the Service Arrangements section in this Guide. Commercial colleagues may suggest specific experts for consideration; however, the final decision on expert selection for health outcomes research rests solely with HEOR.
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