4074024748
Announcing EMD Serono's New
Fertility Technologies Collaborative Research Project (FTCRP) on Gidget
February 17, 2017

EMD Serono, Inc, the U.S. biopharmaceutical business of Merck KGaA, Darmstadt, Germany, is pleased to announce the launch of a new Collaborative Research Project for its Fertility Technology "Gidget". Gidget is a Class I device approved for use by the FDA. This device is an electronic witnessing solution which includes hand-held scanners and a central computer system.

EMD Serono invites qualified researchers to apply for the research project by using the following portal /gidget-ftcrp-emdserono.steeprockinc.com.

The Fertility Technologies Collaborative Research Project ("Project")

EMD Serono has established a legacy of developing innovative drugs and devices, and is now focusing on fertility technologies, for the benefit of patients with infertility. EMD Serono's Fertility Technologies are focused on developing innovations that can improve key areas in the IVF laboratory. Specifically, its new technologies have been designed to provide opportunities for optimization of laboratory processes and for patient outcomes, through innovation and standardization.

The Fertility Technologies Collaborative Research Program (FTCRP) Areas of Interest for Gidget Include:

Evaluation of Gidget compared to standard laboratory operating procedure (SOP) for manual witnessing with the focus on time saved, avoidance of potential human errors, and its effect on workflow in the laboratory.

Program Details:

This Project has been launched to collaborate with IVF laboratory researchers on scientifically-driven studies within the described areas of interest for EMD Serono's Fertility Technology "Gidget". The results from this research collaboration will further support the scientific information obtained to date from the standpoint of optimizing laboratory procedures and patient outcomes.

A fundamental aspect of the Project is that it is collaborative, meaning EMD Serono will actively collaborate with researchers to design clinical studies. In this way, the Project is quite different from EMD Serono's Investigator-Sponsored Studies, which involve unsolicited requests for funding or drug to conduct a study designed entirely by researchers, without EMD Serono involvement on study design and conduct.

Application Process

To apply, researchers must submit a detailed proposal for a research study via EMD Serono's on-line portal at 610-903-1245. The portal contains an Application Form containing mandatory fields for the Proposal.

To apply, researchers must register as a new user on the FTCRP Portal. Please note even if you registered in the past for an EMD Serono ISS, it is important to register as a new user specifically for this portal. Once registered, submit a detailed proposal for a research study via EMD Serono's on-line portal 2252530434. The portal contains an Application Form containing mandatory fields for the Proposal.

The Proposal should be as detailed and complete as possible. In addition to completing the mandatory fields, the study researcher can upload a full protocol to the portal.

Because this is a collaborative research project, we encourage researchers to discuss the design of possible research projects with EMD Serono before submitting a Proposal. To this end, a member of the EMD Serono Medical Team will assist you with the process.

For questions related to the submission process you may contact Brian Bartholdi by email: Brian.bartholdi@emdserono.com or by phone:+1-978-294-1689.

Criteria

In general, EMD Serono will use the following criteria to evaluate Proposals which involve use of Gidget:

(a)alignment with the targeted area of interest provided above
(b)legitimate scientific value
(c)strong scientific rationale
(d)designed to provide meaningful information or conclusions
(e)innovation
(f)feasibility
(g)will further support the scientific information obtained to date for these technologies from the standpoint of optimizing laboratory procedures and patient outcomes.

In addition, EMD Serono will consider whether the researcher has appropriate training and expertise to conduct the research. The Fertility Technology, Gidget equipment will be provided for the duration of the study. In addition, specific consumables will be included and dependent upon the study design. The study budget must be commensurate with and not exceed the legitimate costs to be incurred in carrying out the particular research. The reasonableness of the budget will also be considered.

Finally, EMD Serono will also consider the likelihood that the study will generate quality data and should result in abstract or full manuscript submission to peer reviewed journals.


OVERVIEW OF THE FERTILITY TECHNOLOGIES COLLABORATIVE RESEARCH PROJECT (FTCRP)
February 17, 2017

EMD Serono, Inc, the U.S. biopharmaceutical business of Merck KGaA, Darmstadt, Germany, is pleased to announce the launch of a new Collaborative Research Project for its Fertility Technology "Gidget". Gidget is a Class I device approved for use by the FDA. This device is an electronic witnessing solution which includes hand-held scanners and a central computer system.

EMD Serono invites qualified researchers to apply for the research project by visiting (336) 467-1178.

The Fertility Technologies Collaborative Research Project ("Project")

EMD Serono has established a legacy of developing innovative drugs and devices, and now is targeting fertility technologies, for the benefit of patients with infertility. EMD Serono's Fertility Technologies are focused on developing innovations that can improve key areas in the IVF laboratory. Specifically, its new technologies have been designed to provide opportunities for optimization of laboratory processes and for patient outcomes, through innovation and standardization.

The Fertility Technologies Collaborative Research Program (FT CRP) Areas of Interest for Gidget Include:
  • Evaluation of Gidget compared to standard laboratory operating procedure (SOP) for manual witnessing with the focus on time saved, avoidance of potential human errors, and its effect on workflow in the laboratory.
Program Details:

This Project has been launched to collaborate with IVF laboratory researchers on scientifically-driven studies within the described areas of interest for each of EMD Serono's investigational Fertility Technologies, including Gidget. The results from this research collaboration will further support the scientific infromation obtained to date for these technologies from the standpoint of optimizing laboratory procedures and patient outcomes.

A fundamental aspect for the Project is that it is collaborative, meaning EMD Serono will actively collaborate with researchers to design clinical studies. In this way, the Project is quite different from EMD Serono's Investigator-Sponsored Trials Program, which involves unsolicited requests for funding or drug to conduct a study designed entirely by researchers, without EMD Serono involvement in study design or conduct.

APPLICATION PROCESS

To apply, researchers must register as a new user on the FTCRP Portal. Please note that, because this is a collaborative program, the portal is separate and distinct from EMD Serono's Investigator-Sponsored Trials portal. It is important to register as a new user specifically for this portal at /gidget-ftcrp-emdserono.steeprockinc.com. Once registered, please submit a detailed Proposal for a research study. The portal contains an Application Form containing mandatory fields for the Proposal.

These fields include: title, a detailed description of the study design, the study rationale, objectives, inclusion/exclusion criteria, hypothesis, study population, feasibility, unique or novel feature of the study, outcomes achieved to date, related publications, and budget. The Proposal should be as detailed and complete as possible. In addition to completing the mandatory fields, study researcher can upload a full protocol to the portal.

Because this is a collaborative research project, we encourage researchers to discuss the design of possible research projects with EMD Serono before submitting a Proposal. To this end, a member of the EMD Serono Medical Team will assist you with the process.

For questions related to the submission process you may contact Brian Bartholdi by email: brian.bartholdi@emdserono.com or by phone: +1-978-294-1689.

To facilitate the study design development and the submission of the detailed proposal, user information can found through communications with an EMD Serono medical team member.

REVIEW AND APPROVAL PROCESS
1. Criteria

In general, EMD Serono will use the following criteria to evaluate Proposals which involve use of Gidget:

(a)alignment with the targeted area of interest provided above
(b)legitimate scientific value
(c)strong scientific rationale
(d)designed to provide meaningful information or conclusions
(e)innovation
(f)feasibility
(g)will further support the scientific information obtained to date for these technologies from the standpoint of optimizing laboratory procedures and patient outcomes.

In addition, EMD Serono will consider whether the researcher has appropriate training and expertise to conduct the research. The Gidget will be provided for the duration of the study. The study budget must be commensurate with and not exceed the fair market value costs to be incurred in carrying out the particular research. The reasonableness of the budget will also be considered.

Finally, EMD Serono will also consider the likelihood that the study will generate quality data and result in abstract or full manuscript submission to peer reviewed journals.

2. Approval

There will be a FT CRP Committee which will undertake a review process to assess the scientific merits and other aspects of Proposals discussed above. No research collaboration may be considered approved until after receiving favorable committee review and execution of an approved collaboration agreement.

After approval and any necessary IRB approval, the investigational equipment to be used in the research will be shipped to and installed in the IVF laboratory. The researcher must be trained on the appropriate use of such equipment and related consumables and quality control processes before commencing the research. After completion of the research, such equipment and any related consumables must be returned to EMD Serono.

MONITORING OF RESEARCH PROGRESS
1. Progress Reports

In order to ensure the appropriate progress of FT CRP research studies, researchers will be required to provide updates on the progress of each collaboration on a periodic basis.

2. Final Report and Publication

EMD Serono desires to ensure that research undertaken as part of the FT CRP is completed and analyzed. All researchers will be required to provide EMD Serono with final study results in the form of a final report.

EMD Serono supports the exercise of academic freedom by researchers and expects the results of research to be published, consistent with the company's Publication Policies, whether or not the results are favorable to EMD Serono or their fertility technologies products. Because the FT CRP is collaborative in nature, one or more EMD Serono employees may qualify for authorship under ICMJE principles.

3. Collaboration Reconciliation

At the end of the research project, a collaboration reconciliation will take place to ensure that funds, if any, provided were used solely for approved purposes, and any unused funds are returned to EMD Serono.

The reconciliation will include the following certifications:

  • (i) the study was conducted in accordance with the terms of the collaboration agreement
  • (ii) any unused funds provided by EMD Serono has been returned to the company
  • (iii) all applicable safety reporting obligations (if any) were met.

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