Galderma recognizes the importance of supporting Investigator-Initiated Studies (IISs) that lead to a greater understanding of our therapies and their potential applications, improved patient care, and new ideas for further research.
We accept unsolicited requests for research grants from academic and community-based clinician-scientists who are interested in conducting their own IIS. The application process consists of a two-phase formal evaluation involving a preliminary concept proposal submission that, if accepted, is followed by a more detailed full proposal (protocol) submission.
Support is awarded based upon scientific merit, as well as alignment with our research areas of interest and availability of resources. We may provide research grants in the form of funding, and/or study product; however, we are not the study sponsor and will not assume any sponsor obligations.
All sponsor-investigators who are awarded support must agree to publish the study results regardless of study outcome and provide Galderma with ongoing study updates and closeout and reconciliation reports. Please review the sections below to ensure that you are willing to meet these requirements prior to requesting support.
REQUIREMENTS OF THE SPONSOR INVESTIGATOR
As the sponsor of the study, the investigator and/or institution assume responsibility for all aspects of the study.
- Study design and protocol development
- Institutional and regulatory approvals and reporting
- Study conduct in accordance with ICH GCP Guidelines and all applicable local and regulatory requirements
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Communication of all ongoing study updates (see section below)
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Reconciliation and closeout reporting (see section below)
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Clinical study report submission within 90 days of study completion
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Dissemination of study results in a peer-reviewed publication and/or at a medical meeting within 6 months of study completion
ONGOING STUDY UPDATES
The Investigator must notify Galderma of the following updates for ongoing studies:
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Amendments to the study protocol
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Regulatory re-approvals
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Serious adverse events reports
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Achievement of study milestones related to milestone payments
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Subject enrollment progress (e.g., first subject in, last subject in, last subject out, etc.)
CLOSEOUT & RECONCILIATION REPORTS
In addition to a clinical study report, the Investigator is contractually obligated to provide the following study closeout documentation within 90 days of study completion:
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Budget Reconciliation
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Product Reconciliation
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Adverse Event Reconciliation
CLINICAL STUDY REPORT
A clinical study report (CSR) is required within 90 days of study completion. The CSR should be written in accordance with the ICH Guidance for Structure and Content of Clinical Study Reports. Please refer to our guidance document here. A CSR template is provided for you here.
PUBLICATION
Submission for publication in a peer-reviewed journal is required within 6 months of study completion. All publications should comply with recognized ethical standards concerning publications and authorship, including the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, established by the International Committee of Medical Journal Editors.
Galderma at least 30 days in advance of submission for publication. Additionally, we must receive evidence of submission for publication no later than 6 months following completion of the study. For research support that includes funding, the final milestone payment is dependent on submission for publication or presentation of study results.
Submit a Request
Submissions are accepted on an ongoing basis and must align with our areas of interest in Aesthetics, Consumer Care and Prescription medicine. Only products approved by the U.S. Food and Drug Administration may be provided to support IISs. To view our current areas of interest and portfolio of products available for request, please visit www.galderma.com/us.
REQUESTS THAT WILL BE CONSIDERED
The following IIS study types may be considered for support:
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Prospective clinical or preclinical studies involving Galderma products
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Non-interventional research, such as epidemiology or outcomes studies, where the focus is on scientific understanding of the disease
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In vitro and in vivo studies
REQUESTS THAT WILL NOT BE CONSIDERED
We do not provide support for the following:
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Proposals that are not aligned with our current areas of interest
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Studies that have already started or are completed
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Proposals that are conditioned upon past or future prescriptions or purchases of Galderma products
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Requests that create a conflict of interest for Galderma
Requests are submitted in two-phase process involving a preliminary concept proposal (synopsis) submission that, if accepted, is followed by a more detailed full proposal (protocol)submission. Each proposal is reviewed by an internal committee; this process takes a minimum of 12 weeks. Support is awarded based upon scientific merit, as well as alignment with our research priorities and availability of resources. Following each phase of the process, formal notification will be sent to the Investigator once a decision has been reached. Should additional information be needed for the committee to make a decision, a request for additional information will be issued.
Detailed information regarding each step of this process is provided in the sections below.
CONCEPT PROPOSAL
The following information is required for a concept proposal:
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Study Title
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Study Type
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Indication/Therapeutic Area
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Scientific Background & Rationale
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Primary & Secondary Objectives and Endpoints
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Study Design/Methodology
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Study Duration
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Type of Support Requested (funding, study product, or both)
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Contact Information for the Sponsor, Investigator, and Study Coordinator
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Curriculum Vitae for the Sponsor, all Investigators, and the Study Coordinator (to include publications, trainings on ICH GCP, and clinical trials)
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Medical Licenses for all Investigators
Please note that changes may occur to our requirements as we periodically update our process.
FULL PROPOSAL
If the initial concept is approved, a follow-up request for a full proposal and protocol will be issued. The following information is required for a full proposal:
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Further Details of Study Drug, Treatment and Comparator (if applicable)
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Timeline and Schedule of Events
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Study Endpoint Analysis
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Safety Plan
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Statistical Plan
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Data Management Plan
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Publication Plan
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All-Inclusive Itemized Budget Based on Fair Market Value (FMV) Costs (if funding is requested)
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Detailed Protocol
Please note that changes may occur to our requirements as we periodically update our process.
AGREEMENT
If the full proposal is approved, a contract will be sent for execution between the sponsor, investigator, and Galderma. Support is contingent upon a fully executed contract, compliance with the terms and conditions of the contract, and submission of the following required documentation:
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IRB/EC Approval Letter and Final IRB Approved Protocol
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IND/IDE Application Submission to FDA, if applicable
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Registration on ClinicalTrials.gov, if applicable
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Institutional Sub-W9
BUDGET
We will consider reasonable requests for funding in support of an IIS. All full proposal submissions must include an itemized budget with costs based on fair market value (FMV) evaluations to ensure that the amount of support is appropriate. Requestors may use their own template or the Galderma template that is provided here. Line item allocations should be specified for each aspect of the study, such as study start-up fees (e.g., IRB submission), study visits (e.g., physical exam, vital signs, pregnancy test), and publication costs (e.g., medical writer).
For study-specific items, or equipment that may be required, please provide a rental estimate from a vendor of choice. Please note that we do not provide support for the following:
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Salary and/or benefit payments for Investigators or study staff
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Education/training activities
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Costs that are deemed in excess of fair market value
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Capital equipment purchases (associated rental fees will be considered)
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Construction funds to build new facilities
Types of Eligible Research
Galderma accepts requests for monetary and/or in-kind product support for IISs. Researchers may request support for the following types of studies:
- Prospective clinical or preclinical studies involving Galderma prescription, consumer, or aesthetic products;
- Non-interventional research, such as epidemiology or outcomes studies, where the focus is on scientific understanding of the disease; or
- In-vitro and in-vivo studies.
Galderma supports multi-site studies. However, it is the responsibility of the Investigator to coordinate shipment of study product to other investigational sites.
Products Available for In-Kind Product Support
Galderma may provide in-kind product in support of an IIS. To view our current portfolio of products that are available for request, please visit www.galderma.com/us.
Support That Will Not be Considered
Galderma will not consider requests in support of the following:
- Support or payments made directly to HCPs or other individuals
- Salary and/or benefit payments for Investigators or study staff
- Education/training activities
- Costs that are deemed in excess of fair market value
- Proposals that are not aligned with Galderma areas of interest
- Capital equipment purchases (associated rental fees will be considered)
- Studies that have already started or are completed
- Proposals that are conditioned upon past or future prescriptions or purchases of Galderma products
- Requests that create a conflict of interest for Galderma
- Non U.S.-based HCPs or research
Requests for support are submitted in a two-phase process: (1) a Concept Proposal (synopsis) and (2) a Full Proposal (protocol). All requests for support must be submitted through Galderma’s Medical Grants Portal (“Portal”). Requests submitted through any other means will not be accepted. The steps of the 2-phase submission process are further detailed below:
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Concept Proposal Submission: A Concept Proposal is submitted in the Portal by an Investigator.
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Concept Review: The Concept is routed to an internal committee for review and a written notification of the committee’s decision is sent.
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Request for Full Proposal: If the Concept Proposal is approved, a follow-up request for a Full Proposal (i.e., protocol) is issued.
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Full Proposal Submission: A Full Proposal is submitted in the Portal.
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Full Proposal Review: The Full Proposal is routed to an internal committee for review and a written notification of the committee’s decision is sent.
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Letter of Agreement: If the Full Proposal is approved, a Letter of Agreement (LOA) is executed between the Sponsor, Investigator, and Galderma. Support from Galderma is contingent upon a fully executed LOA, compliance with the terms and conditions of the LOA, and submission of all required documentation as detailed in the LOA.
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Provision of Support: Once a LOA is executed and Galderma receives all required documentation, Galderma provides support for the study and the study may start.
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Payment: Study payments are broken down into milestones. Once a milestone is completed, the Investigator may submit an invoice for completion of the milestone for the corresponding amount. Milestone payments will vary from study to study. Payments will be made by electronic funds transfer (EFT) to the study Sponsor.
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Product: Product will be shipped directly to the Investigator before the study begins. It is the responsibility of the Investigator to notify Galderma of when the first subject is anticipated to receive treatment and request that study product be sent.
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Study Completion: The Investigator is required to provide all reconciliations and a study report, within ninety (90) days of study completion. The Investigator must also submit the results of the study for publication within six (6) months of study completion, whether or not the results are favorable to Galderma or any Galderma product.
Please note that changes may occur as we periodically update our Process.
Submission Deadline
Galderma accepts requests for support on an ongoing basis.
Submission Confirmation
You will receive a notification email confirming the submission of each request for support (i.e., after the submission of a Concept Proposal, and after the submission of a Full Proposal)
Submission Status
You may log into the Portal at any time to check the current status of each submitted request.
Changes After Submission
Once you complete each phase of the submission, no changes can be made. However, if the internal committee requires clarification or has questions about a Concept or Full Proposal, a "Request for Additional Information" will be issued.
Timing for Processing and Review
Review times vary. Typically, each phase of the process (i.e., Concept Proposal and Full Proposal submissions) takes a minimum of 12 weeks. Additional processing time may also be needed around company and national holidays. Please note that Grant Requests may be declined due to insufficient processing time.
Request for Additional Information
A "Request for Additional Information" is sent when additional information is needed in order for the internal committee to make a determination regarding support. If the additional information provided is insufficient or not received in a timely manner, the request may be denied.
Galderma Laboratories, L.P. IIS Request Process
All requests for IIS support must be submitted through the online portal. Submissions or requests through any other means will not be accepted. An internal committee will review and approve or deny all requests for IIS support; the decision will be communicated directly to the requestor with a notification through the portal. Upon approval of a Concept Proposal, a follow-up request for a Full Proposal (i.e., protocol) will be issued. If the Full Proposal is of interest, a Letter of Agreement (LOA) will be sent to the requestor for execution between the Sponsor, Investigator, and GLLP. Support from GLLP is contingent upon a fully executed LOA and submission of all required documentation. Once the study begins, payments will be made to the Sponsor upon completion of pre-determined study milestones. Upon study completion, the Investigator is required to provide all study closeout documentation including a study report within ninety (90) days, as well as submit the results of the study for publication within six (6) months, whether or not the results are favorable to GLLP or any GLLP product. Please note that changes may occur to our requirements as we periodically update our grants process.
Submission Timeframe
GLLP accepts requests for IIS support on an ongoing basis.
Processing and Review Timeframe
Review times vary; however, typically each phase of review (i.e., Concept Proposal and Full Proposal submission) takes a minimum of 8 weeks.
Requests for support are submitted in a two-phase process: (1) a Concept Proposal (synopsis) and (2) a Full Proposal (protocol). All requests for support must be submitted through Galderma’s Medical Grants Portal (“Portal”). Requests submitted through any other means will not be accepted.
Who May Apply
Academic and community-based clinician-scientists who are interested in conducting their own research may apply for IIS support. Qualified individuals should have basic knowledge of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use’s (ICH) Good Clinical Practice (GCP) as evidence by training on ICH GCP, have recent, prior clinical research experience as a Primary or Sub-Investigator, as well as have recent publication or presentation experience involving the results of clinical research.
Concept Proposal Requirements
The following information is required to submit a Concept Proposal:
- Study Title
- Study Type
- Scientific Background & Rationale
- Primary & Secondary Objectives
- Primary & Secondary Endpoints
- Study Design/Methodology
- Study Design
- Study Setting
- Study Population
- Number of Subjects with Rationale
- Inclusion/Exclusion Criteria
- Indication/Therapeutic Area
- Study Duration
- Number of Study Visits
- Name of IRB
- Type of Support Requested from Galderma (monetary support, study product, or a combination of both)
- Curriculum Vitae for the Sponsor, all Investigators, and the Study Coordinator (to include publications, trainings on ICH GCP, and clinical trials)
- Medical Licenses for all Investigators
Please note that changes may occur to our requirements as we periodically update our process.
Full Proposal Requirements
Following the review of the Concept Proposal, Requestors are notified of the decision from the committee. If a Concept Proposal is of interest, a follow-up request for a Full Proposal (i.e., protocol) will be issued. In addition to expanding upon the components of the Concept Proposal, the following information is required to submit a Full Proposal:
- Further Details of Study Drug, Treatment and Comparator (if applicable)
- Description
- Treatment/No Treatment Regimen
- Permitted/Prohibited Concomitant Medications
- Timeline and Schedule of Events
- Study Visits and Procedures
- Duration of Enrollment
- Duration of Treatment
- Duration of Follow-up
- Primary and Secondary Endpoint Analysis
- Safety and Adverse Events
- Adverse Events of Special Interest
- Reporting Procedures
- Statistical Plan
- Sample Size and Power Analysis Justification
- Publication Plan
- Specific Support Requested from Galderma
- All-Inclusive Itemized Budget Based on Fair Market Value (FMV) Costs (if monetary support is being requested)
- Detailed Protocol
Please note that changes may occur to our requirements as we periodically update our process.
Budget
Galderma will consider reasonable requests for funding in support of an IIS. All Full Proposal submissions must include an itemized budget with costs based on fair market value (FMV) evaluations to ensure that the amount of support is appropriate. Requestors may use the Galderma template that is provided here, however other templates are accepted as well. Line item allocations should be specified for each aspect of the study, such as study start-up fees (e.g., IRB submission), study visits (e.g., physical exam, vital signs, pregnancy test), and publication costs (e.g., medical writer).
For study-specific items, or equipment that may be required, please provide a rental estimate from a vendor of choice. Please note that the following costs will not be supported by Galderma and should not be incorporated into study budgets:
- Salary and/or benefit payments for Investigators or study staff;
- Education/training activities;
- Costs that are deemed in excess of fair market value;
- Capital equipment purchases (Associated rental fees will be considered); or
- Construction funds to build new facilities.
Following the review of the Full Proposal, Requestors will be notified of the decision from the committee. If the Full Proposal is approved, a Letter of Agreement (LOA) will be sent for execution between the Sponsor, Investigator, and Galderma. Support from Galderma is contingent upon a fully executed LOA, compliance with the terms and conditions of the LOA, and submission of all required documentation as listed below:
- IRB/IEC Approval Letter and Final IRB Approved Protocol;
- IND/IDE Application Submission to FDA, if applicable; and
- Registration on www.clinicaltrials.gov, if applicable.
- Please note that the study Sponsor and Investigator(s) must agree to conduct the study in accordance with ICH GCP Guidelines and all applicable local, state, federal laws, rules and regulations.
IRB/IEC Approval
The Investigator is responsible for ensuring that the study is approved by and subject to continuing oversight by an IRB constituted and operating in accordance with
21 CFR Part 56, and will submit all re-approvals as required by local laws and regulations to Galderma.
IND/IDE Submission
The Investigator is responsible for all matters and reporting related to
Investigational New Drug Application (“IND”) requirements and
Investigational Device Exemption (“IDE”) requirements in coordination with the FDA and an IRB. Upon full execution of a Letter of Agreement (LOA), Galderma may provide a “Right of Reference” letter to the FDA on behalf of the Investigator, as a requirement of the application process.
ClinicalTrials.gov Registration
The Investigator is responsible for registering the study on
www.clinicaltrials.gov for any study involving human subjects. The purpose of clinical trial registration is to prevent selective publication and selective reporting of research outcomes, to prevent unnecessary duplication of research efforts, to help patients and the public know what trials are planned or ongoing into which they might want to enroll, and to help give ethics review boards considering approval of new studies a view of similar work and data relevant to the research they are considering. Also, The International Committee of Medical Journal Editors (ICMJE) requires trial registration for certain drugs and medical devices as a condition of the publication of research results generated by clinical trials.
Requirements of the Sponsor and Investigator
The study Sponsor and Investigator must ensure that the study is conducted in accordance with ICH GCP Guidelines and all applicable local, state, federal laws, rules and regulations. The Investigator must assume all regulatory responsibilities including, but not limited to, obtaining all IRB/IEC approvals and re-approvals, regulatory approvals including IND/IDE submissions, and all safety-reporting obligations to local regulatory authorities, as well as, to the FDA and Galderma. Investigators are also required to:
- Register the study on www.clinicaltrials.gov, as well as, provide status updates and post-study results, (for trials involving human subjects);
- Clearly label all product, "For Investigational Use Only" so that the product is clearly identified as product being used in a clinical study and is not for commercial use;
- Immediately notify Galderma of any protocol amendments submitted to the IRB/IEC;
- Notify the FDA, IRB, and Galderma of any severe adverse event possibly related to a study product for any study within 24 hours of receiving notification of such an event;
- Submit frequent progress reports to Galderma regarding study status;
- Submit all study close-out documentation to Galderma within 90 days of study completion;
- Submit the results of the study for publication within six (6) months of study completion, whether or not the results are favorable to Galderma or any Galderma Product; and
- Comply with all terms, conditions, and requirements of the LOA.
Updates
The Investigator must submit the following updates to Galderma while the Study is ongoing:
- Amendments to Study Approval;
- Safety Reporting;
- Pre-Publication Review; and
- Progress Reports.
Study Closeout Requirements and Reconciliations
The Investigator is contractually obligated to provide Galderma with all study closeout documentation within ninety (90) days of study completion. If Galderma does not receive the required study closeout materials, you will not be eligible to apply for future support. Additionally, for research support that includes funding, the final milestone payment is dependent on proof of submission for publication or presentation of study results within 6 months of study completion. Study closeout documents include:
- Study Report;
- Budget Reconciliation;
- Product Reconciliation;
- Adverse Event Reconciliation; and
- Evidence of Submission for Publication.
Amendments to Study Approval
The Investigator will immediately notify Galderma of any action to amend the study protocol, and of any required periodic updates from regulatory authorities.
Safety Reporting
The Investigator will ensure that all adverse events whether related or unrelated to study product, are reported according to the terms of the study protocol. The Investigator will report all serious adverse events (SAE) to the FDA, IRB, and Galderma. The Investigator will also provide a complete reconciliation of all adverse events as part of the study closeout documentation.
Publication
Selection and submission for publication/presentation is at the discretion of the Investigator; however, submission to a peer-reviewed journal is required to receive support from Galderma. All publications should comply with recognized ethical standards concerning publications and authorship, including the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, established by the International Committee of Medical Journal Editors.
A copy of all draft publications that report the results of Galderma supported IISs must be sent to Galderma at least thirty (30) days in advance of submission for publication to allow Galderma to conduct a courtesy review. Additionally, Galderma must receive evidence of submission for publication no later than six (6) months following completion of the study. For research support that includes funding, the final milestone payment is dependent on submission for publication or presentation of study results.
Progress Reports
Reports noting study progress and/or reaching any major milestones (e.g., IRB approval, first subject in, last subject in, last subject out, etc.) will be sent to Galderma by the study Investigator. Progress report timing will be dependent on the length of the study and may be monthly, bi-monthly, or quarterly. A failure to provide progress reports or provide notification of attaining a major milestone may be interpreted as a lack of study progress and could result in support being withdrawn.
Study Report
Budget and Product Reconciliations
Reports certifying that all support was used in accordance with the study and declaring any unused funds or product to return/destroy will be sent to Galderma following the completion of the study. The Sponsor will be required to refund unused grant funds, or return/destroy unused or partially used product after the study is completed.
We are committed to maintaining integrity in all of our professional relationships. We operate under the highest ethical standards and in full compliance with all applicable laws, regulations, industry codes, and guidelines. Approval of IIS support is never related to or conditioned upon past or future prescriptions or purchases of Galderma products. Furthermore, we do not offer, or provide funding to encourage or to reward the prescription, purchase, ordering, or recommending of Galderma products.
Our grant review and approval process is in full accordance with the recommendations and the guidance of the U.S. Food and Drug Administration (FDA), the Pharmaceutical Research and Manufacturers Association (PhRMA), the Office of Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers, the PhRMA Code on Interaction with Health Care Professionals, the AdvaMed Code of Ethics on Interactions with Health Care Providers, and National Physician Payment Transparency Program: Open Payments "Physician Payment Sunshine Act", as well as internal Galderma policies.
Submission Confidentiality
By submitting materials for review, you agree that the information is not confidential, nor proprietary, and may be referred to a number of different persons at Galderma to determine the level of interest in supporting your request. A Confidential Disclosure Agreement (CDA) will be executed between parties for each submitted concept.
Disclosure of Support
Publications or other presentation of data derived from the IIS must be marked with an acknowledgement that the study was conducted with financial and/or in-kind support from Galderma, as a collaborator.