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
WE PROTECT & SECURE YOUR IDEA
Your idea is, and will always be, yours and yours alone.
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.
WE NEGOTIATE
YOUR TRIAL
Our business development team will confidentially present your idea to potential funders, searching for a win-win synergy.
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.
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
1
Sharing your idea with us
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Guaranteed confidentiality
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We analyze the Strategic potential of the idea
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Our KOL network can strengthen YOUR idea
Synopsis development
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Generation of solid rationale
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Addition of statistical assumptions
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Selection of best potential partners
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We propose relevant translational research
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You approve the final synopsis
2
Secure funding
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We pitch the proposal to industry partners
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We build operational plan and budget
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We negotiate the proposal
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We present the idea to other companies, if needed
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You approve all relevant decisions
3
Trial Set up and Clinical trial Management
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Full protocol writing
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We assume the role of Sponsor
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We coordinate your publications and presentations
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You keep publication rights and access to all data
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Any potential financial benefits will be shared
4
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We generate additional hypothesis to test in subsequent studies
Further study opportunities
5
START OF PROPOSAL DEVELOPMENT
SYNOPSIS APPROVAL
FUNDING ESTABLISHED
FINAL RESULTS PUBLISHED
SOME OF OUR STUDIES
THINK TANK MEETING 2022
We had the pleasure to host a Think Tank Meeting in Barcelona: 5 Key Opinion Leaders (KOLs) in breast cancer field and over 25 breast cancer oncologists from emerging markets of LATAM, Asia and AfME, were invited to a 3-day-dynamic, with the aim of establishing new connections with their colleagues worldwide while learning how to design innovative and strategic trials.
If you’re interested in taking part of the next Think Tank Meeting or would like to sponsor it, don’t hesitate to contact us!
SOME CLINICAL EXPERTS COLLABORATING WITH MEDSIR
JAVIER
CORTÉS
Medical Oncologist
MD, PhD
ANTONIO
LLOMBART
Medical Oncologist
MD, PhD
MARINA GARASSINO
Medical Oncologist
MD, PhD
FREDERIK MARMÉ
Gynecologist
MD, PhD
MARTA VAZ-BAPTISTA
Medical Oncologist
MD
JOSEP MARIA
PIULATS
Medical Oncologist
MD, PhD
NIKI KARACHALIOU
Medical Oncologist
MD, PhD
ANTONIO
CALLES
Medical Oncologist MD, PhD
PETER SCHMID
Medical Oncologis MD, PhD
JORDI REMON
Medical Oncologist
MD, PhD
JOSEPH GLIGOROV
Medical Oncologist
MD, PhD
NOEMÍ REGUART
Medical Oncologist
MD, PhD
PETER
KAUFMAN
Medical Oncologist
MD, PhD
JOAN CARLES
Medical Oncologist
MD, PhD
JOSÉ PÉREZ
Medical Oncologist
MD, PhD
JAVIER GARDE
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.
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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. ▪ We are interested in science. We might want to generate additional research/publications with the data collected, but we will never do it without the company’s knowledge.
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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.
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WHAT IS THE ADDED VALUE OF CHOOSING MEDSIR 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, so 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 than accrual speed).
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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.