TURN YOUR IDEA INTO A FULLY- FUNDED CLINICAL TRIAL

IF YOU HAVE AN IDEA FOR AN INVESTIGATOR-INITIATED CLINICAL STUDY, MEDSIR CAN OFFER YOU A CROSS-FUNCTIONAL SYSTEM FULLY INTEGRATING THE STRATEGIC, SCIENTIFIC, AND OPERATIONAL ASPECTS OF INDEPENDENT CLINICAL RESEARCH.

WE WANT TO HELP YOU TURN YOUR INITIAL CONCEPT INTO A FULLY-FUNDED CLINICAL TRIAL!

YOUR IDEA, OUR ENDEAVOR

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WE PROTECT & SECURE YOUR IDEA

Your idea is, and will always be, yours and yours alone.

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WE CONVERT YOUR IDEA INTO A STRATEGIC
CLINICAL TRIAL


Our experience in clinical trials and market intelligence will help you design a full trial protocol that makes sense for patients, science, and companies.

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WE NEGOTIATE
YOUR TRIAL


Our business development team will confidentially present your idea to potential funders, searching for a win-win synergy.

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WE INVITE YOU ON BOARD AS CAPTAIN

You will lead the process from study start-up all the way through to the publication of study results.

MEDSIR CAN BE OF INTEREST FOR YOU IF...

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You are a clinical investigator in oncology with a concept for a novel trial and you would like to benefit, from a full support structure able to help you through all stages of development of your idea, free from any cost, (statistical design, medical writing, budget creation, securing of the funding, regulatory and operational management, etc.) while protecting your intellectual property at all times.

WHAT WE DO FOR CLINICAL INVESTIGATORS

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1

Sharing your idea with us

  • Guaranteed confidentiality

  • We analyze the Strategic potential of the idea

  • Our KOL network can strengthen YOUR idea

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Synopsis development

  • Generation of solid rationale

  • Addition of statistical assumptions

  • Selection of best potential partners

  • We propose relevant translational research

  • You approve the final synopsis

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2

Secure funding

  • We pitch the proposal to industry partners

  • We build operational plan and budget

  • We negotiate the proposal

  • We present the idea to other companies, if needed

  • You approve all relevant decisions

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3

Trial Set up and Clinical trial Management

  • Full protocol writing

  • We assume the role of Sponsor

  • We coordinate your publications and presentations

  • You keep publication rights and access to all data

  • Any potential financial benefits will be shared

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4

  • We generate additional hypothesis to test in subsequent studies

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Further study opportunities

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5

START OF PROPOSAL DEVELOPMENT

SYNOPSIS APPROVAL

FUNDING ESTABLISHED 

FINAL RESULTS PUBLISHED

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MEDSIR HELPS YOU CONVERT YOUR RESEARCH IDEA INTO A BRIGHTER FUTURE FOR CANCER PATIENTS

SOME OF OUR STUDIES

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PHERGAIN

BREAST

Chemotherapy-free trastuzumab and pertuzumab in HER2-positive breast cancer: A FDG-PET response-adapted strategy

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SLLIP

LUNG

Spanish Lung Liquid vs. Invasive biopsy Program (SLLIP)

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ORPHEUS

PENIS

Phase II Study of the Efficacy of INCMGA00012 in Penile Squamous Cell Carcinoma

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PARSIFAL

BREAST

Palbociclib with fulvestrant or letrozole for HER-, ER+ metastatic breast cancer

SOME CLINICAL EXPERTS COLLABORATING WITH MEDSIR

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Peter Schmid

PETER SCHMID

Medical Oncologis MD, PhD

Joan Maurel

JORDI 

REMON

Medical Oncologist 
MD, PhD

Joseph Gligorov

JOSEPH GLIGOROV

Medical Oncologist 
MD, PhD

Noemí Reguart

NOEMÍ REGUART

Medical Oncologist 
MD, PhD

Andrés Poveda

PETER

KAUFMAN

Medical Oncologist 
MD, PhD

Joan Carles

JOAN CARLES

Medical Oncologist 
MD, PhD

José Pérez

JOSÉ PÉREZ

Medical Oncologist 
MD, PhD

Javier Garde

JAVIER GARDE

Medical Oncologist 
MD, PhD

David Páez

ANTONIO

CALLES

Medical Oncologist MD, PhD

Niki Karachaliou

NIKI KARACHALIOU

Medical Oncologist 
MD, PhD

Josep Maria Piulats

JOSEP MARIA

PIULATS

Medical Oncologist 
MD, PhD

Esther Holgado

MARINA GARASSINO

Medical Oncologist 
MD, PhD

Frederik Marmé

FREDERIK MARMÉ

Gynecologist 
MD, PhD

Ignacio Romero

EDWARD

GARON

Medical Oncologist 
MD, PhD

José Enrique Alés

ANTONIO

LLOMBART

Medical Oncologist 
MD, PhD

Elena Aguirre

JAVIER

CORTÉS

Medical Oncologist 
MD, PhD

FREQUENTLY ASKED QUESTIONS

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WHY IS MEDSIR THE SPONSOR?


Science is our goal: we are not a CRO, we only run studies with strategies and molecules we truly believe in. ▪ Agility in bureaucracy with agencies, steering committees, and vendors is key so that we can adapt the initial plan when new risks are identified. Also, as the sponsor we can streamline the management of the clinical trial. ▪ We favor a collaborative approach for clinical research. Even if MEDSIR acts as the Sponsor, collaborating companies are involved in all relevant scientific and operational decisions, and can even be part of the Steering Committee. Likewise, the final trial database is fully shared with collaborating companies. ▪ Acting as a Sponsor allows us not to charge consultant fees since technically, we are asking for financial support from the company to run a MEDSIR study. ▪ Some operational costs can be reduced for independent studies in which the sponsor has no commercial interest.




WHO HAS THE INTELLECTUAL PROPERTY? WILL MEDSIR HAVE EXPLOITATION RIGHTS?


▪ The data collected in a clinical trial belongs to the Sponsor. However, we are willing to grant full access to all the data generated in the trial (not only published results, but the full database) to collaborating companies in perpetuity and free of any additional charges. ▪ All exploitation rights belong to the collaborating company. We are completely independent and have no commercial interests in the result of the trial. The company has access to any data needed for potential submissions to regulatory agencies. ▪ We maintain publication rights for the trial results, but the collaborating company can be included if they choose to. ▪ We are interested in science. We might want to generate additional research/publications with the data collected but will never do it without the company’s knowledge.




WHAT IS THE ADDED VALUE OF MEDSIR VS COMMON INSTITUTIONS THAT PROMOTE ACADEMIC CLINICAL RESEARCH?


▪ We have a global operational structure. ▪ We have a flexible model which is not limited to any pre-defined network of sites and/or investigators. We involve the sites that make more sense for each particular project. ▪ We believe in collaborative clinical research. We want to consider the strategic needs of collaborating companies and are willing to involve them in all relevant decisions regarding the design and management of the project. ▪ We strive to professionalize independent clinical research applying industry quality standards. ▪ We are very agile in the presentation and development of potential ideas. Time is of the essence in the volatile field of clinical development in oncology.




WHAT IS THE ADDED VALUE VS A CRO?


▪ We generate added value with our scientific expertise through the initial idea generation and design. ▪ We present closed budgets with shared risk: trial speed is in our own interest. ▪ Our model streamlines clinical research to increase speed and reduce costs. ▪ We are very proactive in controlling risks and adapting the operational plan to changing needs, if needed. We are fighting for OUR STUDY. ▪ We guarantee the full engagement of KOLs who thoroughly believe in the scientific and clinical potential of the proposals they help develop. ▪ We understand that time spent from first idea generation until start-up is crucial (maybe even more so that accrual speed).




WHOM DO I NEED TO CONTACT TO LEARN MORE ON HOW MEDSIR’S MODEL CAN HELP TO DEVELOP MY PIPELINE?


Our team is available when you need it, just fill out this form and we will contact you as soon as possible.





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TURN YOUR IDEA INTO A FULLY FUNDED CLINICAL TRIAL

COLLABORATE WITH MEDSIR ON THE DEVELOPMENT OF YOUR IDEA IN ORDER TO FIND THE NEXT GROUNDBREAKING THERAPY ABLE TO IMPROVE THE LIVES OF CANCER PATIENTS WORLDWIDE.

Ready to turn your idea into reality?

If you have an idea for an investigator-initiated clinical trial and would like to take advantage of our support structure to fully develop it, fill in the form below and get in touch with us!

We are here to support you!

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