Presentación de negocios

A NOVEL CLINICAL CANCER RESEARCH MODEL FOR THE DEVELOPMENT OF YOUR PIPELINE

MEDSIR IS A LEADER IN CANCER CLINICAL RESEARCH COMMITTED TO HELPING BIOTECH COMPANIES IN THE DESIGN OF THE BEST STRATEGIES FOR THE DEVELOPMENT OF THEIR PIPELINE. MEDSIR MAKES THIS POSSIBLE THROUGH A NOVEL RESEARCH MODEL THAT PROVIDES THE BEST PERKS OF ACADEMIC RESEARCH AND THE MAIN ADVANTAGES OF COMPANY-SPONSORED RESEARCH

A NEW MODEL FOR DRUG CLINICAL DEVELOPMENT 

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MAIN DRAWBACKS OF TRADITIONAL 
COMPANY-SPONSORED (CRO-BASED) MODEL

MAIN DRAWBACKS OF TRADITIONAL ACADEMIC/INVESTIGATOR-SPONSORED MODEL

Generation of a network of advisors is costly and time consuming​

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Delays in accrual and in the generation of data

MEDSIR’s network of oncology experts and KOLs can readily propose ideas for the development of your pipeline free of cost and with no commitment on your end

MEDSIR’s innovative model streamlines clinical research to speed up all processes of a clinical trial

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RISK

SOLUTION

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Limited capacity to generate clinical development ideas

Limited company involvement in study design and management

MEDSIR can give you access to proposals in different clinical settings from a pantumoral network of specialists in all liquid and solid tumors

MEDSIR’s favors a collaborative approach that considers the strategic interests of companies at all times, including continuous full data access

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RISK

SOLUTION

Limited KOL engagement or scientific credibility

Limited capacity to rigorously manage all bureaucratic aspects of clinical research

MEDSIR studies are led by experts in the field, guaranteeing their personal engagement and increasing the consideration of the results in the scientific community

MEDSIR has a cross-functional structure integrating both scientific excellence and a professionalization of operational tasks to industry standards

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RISK

SOLUTION

Lack of certainty regarding final CRO costs

Lack of operative reach outside of pre-defined collaborative structures

MEDSIR presents closed, milestone-based budgets where risk is shared

MEDSIR can work with the right sites for each trial anywhere in the world

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RISK

SOLUTION

WHAT WE DO FOR HEALTHCARE COMPANIES

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Strategic proposal for the clinical development of your drug presentation

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  • Your pipeline is introduced to our KOLs

  • Definition of key settings with unmet clinical needs

  • Strategic clinical trial design

  • Collaborative discussion to include your strategic interests

  • Free of charge and with no commitment

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SYNOPSIS APPROVAL

LOI SIGNED

FINAL CONTRACT

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DELIVERY OF CLINICAL STUDY REPORT AND FINAL PUBLICATION

MEDSIR CAN BE OF INTEREST FOR YOU IF...

The pipeline of your biotech/pharma company contains products with potential application in oncology that are in clinical development (or about to start it), and you would like to receive insights from a network of experts and KOLs about the best, most cost-effective strategies to reach the market, with no prior commitment on your end.​

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  • Exploration of further scenarios to boost the development of your drug

Further development opportunities

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Clinical trial execution

  • Clinical trial full management

  • You can join the steering committee

  • Full data access

  • We can share publication rights

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Clinical trial set up

  • Initial letter of intent signature

  • Study protocol generation

  • Preliminary operational activities

  • Milestone-based, full-service contract signature

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Operational plan and budget construction

  • Timelines, sites, countries

  • Inclusion of the company’s operational preferences

  • Closed budgets with shared risk

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SCIENTIFIC AND OPERATIONAL EXCELLENCE

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MEDSIR can help put young molecules on the right track or allow established molecules to consolidate drug positioning.

 

We can assist your company in the development of any health-related product, including drugs, diagnostic tools, technologies, etc.

 

We aim to streamline all types of clinical research by implementing organizational structures that improve human and economic resource efficiency, producing win-win situations for all parties involved.​

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STRATEGIC

CONSULTANCY

SCIENTIFIC

ADVISING

TRIAL

DESIGN

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GLOBAL OPERATIONAL

STRUCTURE

ACCRUAL

OPTIMIZATION

DATA

ANALYSIS

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MEDSIR IN NUMBERS

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COLLABORATORS FROM INDUSTRY AND ACADEMIA

SOME OF OUR CLINICAL TRIALS

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PHERGAIN

BREAST

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

MORE INFO
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SLLIP

LUNG

Spanish Lung Liquid vs. Invasive biopsy Program (SLLIP)

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MORE INFO
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ORPHEUS

PENIS

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

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MORE INFO
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PARSIFAL

BREAST

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

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MORE INFO

SOME CLINICAL EXPERTS COLLABORATING
WITH MEDSIR

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JAVIER

CORTÉS

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Medical Oncologist 
MD, PhD

PETER SCHMID

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Medical Oncologist MD, PhD

ANTONIO

LLOMBART

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Medical Oncologist 
MD, PhD

JORDI 

REMON

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Medical Oncologist 
MD, PhD

EDWARD

GARON

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Medical Oncologist 
MD

JOSEPH GLIGOROV

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Medical Oncologist 
MD, PhD

FREDERIK MARMÉ

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Gynecologist 
MD

NOEMÍ REGUART

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Medical Oncologist 
MD, PhD

MARINA GARASSINO

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Medical Oncologist 
MD, PhD

PETER

KAUFMAN

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Medical Oncologist 
MD

JOAN CARLES

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Medical Oncologist 
MD, PhD

JOSEP MARIA

PIULATS

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Medical

Oncologist 
MD, PhD

NIKI KARACHALIOU

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Medical Oncologist 
MD, PhD

JOSÉ
PÉREZ

Medical Oncologist 
MD, PhD

ANTONIO

CALLES

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Medical Oncologist MD, PhD

JAVIER GARDE

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Medical Oncologist 
MD

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.



GET THE SUPPORT OF OUR NETWORK OF ONCOLOGY KOLS IN THE DEVELOPMENT OF YOUR PIPELINE

MEDSIR HELPS HEALTH COMPANIES NAVIGATE ALL STAGES OF CLINICAL DEVELOPMENT BY OFFERING A NETWORK OF EXPERTS AND A CROSS-FUNCTIONAL SYSTEM FULLY INTEGRATING THE STRATEGIC, SCIENTIFIC AND OPERATIONAL ASPECTS OF CLINICAL RESEARCH. WE GENERATE HIGH-QUALITY SCIENTIFIC EVIDENCE AND FOLLOW THE MOST ADEQUATE DEVELOPMENT STRATEGY TO CONSOLIDATE THE POSITION OF YOUR PRODUCTS IN THE MARKET.

 

WE CAN ASSIST YOU IN DEVELOPING YOUR INVESTIGATIONAL NEW DRUG!

CONTACT US

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If you are looking for the best strategy for the development of your pipeline through an innovative, cross-functional model able to ensure investigator engagement, scientific excellence, and streamlined trial management, fill in the form below and get in touch with us!

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We are here to support you!

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Before you sign the application, you should read the basic information on data protection listed here.