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Recent Medical Trials Inquiries

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Medical Device Clinical Operations

We are looking for a clinical operations expert who has good knowledge of nsr and sr studies and how medical device trials are conducted. We would seek consultation from this expert and would like to engage in an hourly basis. Kindly share information on the following: 1. What is your experience in clinical operations of medical devices? 2. Are you an expert at fda regulations for medical device clinical trials and iso 14155? 3. Are you also an expert with clinical trial regulatory requirements of australia, canada? Please describe a little. 4. What is your hourly rate? 5. Would you be available for a 2 -3 hours discussion every week? 6. Where are you located? 7. Have you written/reviewed clinical operations sops? Thanks a lot!

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    Clinical Trial Investigation

    I'm looking to talk to clinical trial principal investigators, medical researchers who have run or are running clinical trials, about their experiences.

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      Christopher |Zintro Expert

      I have extensive experience with clinical trial design and execution as well as is endpoint design, ...

      44 Minutes Later
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      David |CEO/Medical Director

      I have 10 years of principal *****rience and would be happy to assist. ...

      55 Minutes Later
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      Humberto |VP Clinical Research / Pharmacovigilance

      I have over 25 yers of experience in practically every phase of clinical research, although mostly l...

      1 Hour Later
    +54 Other Responses
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    Clinical Trial Management Software

    Topic: clinical trial management software geographical scope: north america / europe industry: pharmaceuticals / biopharmaceuticals / generics job category: it / data management, clinical trial management, corporate management, project management, r&d, formulation, analytical testing availability: ~1 hour phone interview anytime during the weeks of march 16 – march 27, 2015 hello, we are conducting research on clinical trial software use in the pharmaceutical / biopharmaceutical markets. We are interested in understanding key reasons, which influence the decision process of choosing one software over another; identifying perceived strengths and weaknesses with regards to the software; and what (if any) are suggested improvements or innovations currently lacking in the clinical trial software market. Qualified respondents must work for a company that currently utilizes clinical trial management software and possess familiarity of the software’s user interface. Additionally, we are interested in speaking with persons who are currently working in the software / services market in order to obtain a more complete picture of the types of drivers which customers are looking for when searching for clinical trial software. If you feel you can offer insights into this area of research please contact us immediately as we only require 8 candidates for this portion of the research.

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      Bellraj |Clinical Informatics Specialist

      Please check my profile....

      1.5 Hours Later
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      Vijay |Clinical Project Management Consultant

      Hi there, I have managed number of clinical trials in past 12 years and have helped developing vari...

      1.5 Hours Later
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      Patricia |Life Sciences, Health & Wellness Technol

      I have extensive experience in clinical trials.software and strategy....

      1.6 Hours Later
    +18 Other Responses
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    Blinded Clinical Trials

    I am looking for an expert who can guide me about the un-blinded monitoring process in blinded clinical trials and help me understand how pharma companies approach un-blinded monitoring. Do they source from a single supplier/multiple suppliers or do they appoint an in-house un-blinded monitor. Please get in touch asap. This is a little urgent. Thanks!

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      Xavier |CEO

      I have a long experience of blinded clinical trial, even when blinding is challenging or even impos...

      10 Minutes Later
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      Vijay |Clinical Project Management Consultant

      Hi there, I have experience in managing clinical trial project in different settings, industry & ac...

      2 Hours Later
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      Susanne |Independent Consultant, Director, Vice P

      Hi for your background ***** get up to speed, look into FDA's web site drugs side and check...

      4.7 Hours Later
    +11 Other Responses
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    Fda Medical Device

    Need an expert on the reasons for and uses of data collection related to the used of a medical device after trial completed but before marketing approval under continued access

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      Sujatha |Clinical research consultant

      I have done a continued access for a medical device and can discuss the pros and cons if you are int...

      6.4 Hours Later
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      Peter |COO

      Can you be slightly more specific and descriptive as to what your need is. Peter...

      7.1 Hours Later
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      Jim |Principal

      I have expertise in this area....

      7.6 Hours Later
    +10 Other Responses
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    Clinical Trial

    This is a full-time employment opportunity for a clinical trial manager (ctm) in the san francisco area. -responsible for coordinating and monitoring the day-to-day logistics of our clinical trials. Functions: -manage clinical trial operations including vendor performance, internal/external metrics, and communication of project status within the project team -manage and track completion of study start-up, conduct, and closeout activities to industry and corporate standards -ensure the progress and completion of projects according to timelines -prepare and present project specific updates -lead or assist in the writing of clinical documents such as protocols, study reports, study manuals, and annual reports -monitor safety surveillance and reporting activities -oversee data management processes including collection and cleaning of clinical database, reconciliation of clinical and safety databases, and data interpretation and evaluation -coordinate dsmb/safety reviews inline with charter and overall study parameters -assist in the construction of clinical development processes including development and writing of sops, creation and organization of study trial master files, and clarification of organization and workflow structures -plan, generate, and track study timelines and trial budgets -site management activities including: review monitoring reports, interact with study monitors, track site errors or other indicators of site difficulties, identification of potential problem sites and development of corrective action plans as required, acting as our contact, as needed, for clinical sites experience: -ba/bs degree in biological science or nursing required (equivalent experience may be accepted) -5+ years of clinical research in the biotechnology/pharmaceutical industry -3+ years of multi-center clinical trial management experience, specifically experience in phase 2, phase 3 us & international clinical trials -experience managing cros, central laboratories, and other clinical study vendors -experience preparing clinical trial budgets and contracts -knowledge of ich-gcps and 21 cfr is required -experience in metabolic/hepatic drug development is desirable -experience with ivrs and/or edc is desirable

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      Arthur |

      To whom it may concern, I am currently Director of drug development at a small biotech firm, Bellus...

      1 Day Later
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      Saurabh |Consultant

      I have been involved with *****ures including research on ***** a drug. Please c...

      1.5 Days Later
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      Mike |Zintro Expert

      Dear Sirs: I feel that I would be an outstanding ***** this position based on my work histor...

      2.1 Days Later
    +24 Other Responses
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    Saas For Clinical Trials - Srm Research

    We are a global market research firm and are seeking experts who can assist us with information about ‘medidata solutions’ as a candidate for preferred supplier in the eclinical solutions space key questions: please elaborate on following questions for “medidata solutions” as one of the suppliers: 1. How competitive is medidata solutions as compared to other vendors in terms of quality, cost and innovation? 2. Comment on supplier readiness on different areas of opportunities – e.G. Cost reduction, innovation, risk mitigation etc. 3. Mention a few srm initiatives between medidata solutions and top biotechnology or pharmaceutical companies. 4. Mention major clients and their present spend with medidata solutions? 5. How does medidata solutions rank as a eclinical solutions provider when compared to similar companies in this space? 6. What are the key negotiation levers at supplier and industry level? 7. How does medidata solutions plan to manage competition in future? 8. List of top 10-20 accounts (clients) in the eclinical solutions space that medidata solutions is a supplier for. Top 5 cash cows for medidata solutions and estimated account sizes ($ value). Ideal candidates should have deep knowledge of medidata solutions and its capabilities, financials and client structure we are looking for a phone consult for a time of 1 hour to discuss all points mentioned above. Kindly drop in a note with your cv/relevant experience in the decentralized clinical trial market, if you are interested to proceed.

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      Clinical Trial Investigators

      We are looking for an expert who can help us do a clinical trial investigator fees / role benchmarking. 1) standardize how high range benchmarks are calculated for investigator fees; e.G. What percentile (50th, 75th, 80th, 90th, 100th ) is used by each segment of the industry to set the upper limit for investigator fees benchmarks 2) is inflation included in the calculations? Is this assessed every year or projected at the time of the contract. 3) how are companies organized around the generation of fmv (per segment/ per region where applicable)? Centrally managed by internal team? Part of operations or stand alone 4) to what level is fmv assessed? Line item, visit, patient; how is overhead assessed is there a company maximum? What is the governance for companies that are above the upper limit of the benchmark for fmv 5) how are the negotiations managed with the investigators? Centrally by internal team, decentralized through regional functions, cro only, specific service provided by specialty vendor, online tool? 6) what is tco for other companies per segment? 7) how are the contractual obligations managed? (automatic feed to electronic data, investigator tracking on central database?) 8) what are the triggers for payment release of investigator fees? Is it recruitment, visit completion, availability of data/clean data? 9) is the processing of invoices from investigators managed centrally (specialist team receiving information from all investigators worldwide?) 10) how are investigators paid?

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        Clinical Evaluation

        I'm looking for assistance in writing/creating a clinical evaluation for a class i medical device.

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          Susanne |Independent Consultant, Director, Vice P

          I have written many of them for my clients for the CE Mark ***** to renew their certificati...

          4 Minutes Later
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          Trina |Medical Writer and Regulatory Specialist

          Hello: I have extensive experience writing Class I and Class II Clinical *****rts. I hav...

          15 Minutes Later
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          Neil |Owner

          Our firm has years of experience *****e documents. ...

          1.7 Hours Later
        +11 Other Responses
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        Clinical Trials Ai Platform

        We are looking for experts who can provide their insights and feedback to a startup seeking equity investment. Startup description: design & conduct better clinical trials. Making clinical trials seamless by bringing together the best and most important functionality of study design & protocol optimization, trial administration, data collection & task management all in one intelligent system. Experts that have interest, knowledge or background in: industry: healthcare, clinical trials, pharmaceutical, life sciences, health and wellness technology: healthcare it, deep learning, ai, end-to-end platforms who we are: we are an online investment platform working to provide a fair and transparent process for startup evaluations and that selects the companies that will outperform other startups in the next three to ten years. Who you are: you do not need to be an experienced angel investor to be a valuable member of the evaluation team. We seek a diverse group with expertise that may cover the market, business model, technology and customers of the startup company. However, if you are an accredited investor, you have the option (but not an obligation) to invest as little as $1000 fee- and carry-free in the startup company if the resulting evaluation leads to an investment. What you will do: as a participating evaluation team member, you will answer a set of questions and rate the comments and feedback of other evaluators. (this is an all volunteer community of industry experts and investors that evaluate startups, requiring about 2 hours total of your time over about 2 weeks.) what’s in it for you: - an inside look at cutting-edge technology or go-to-market approaches - introductions to company management, upon request - collaboration with like-minded experts who are on your evaluation team - contributing to creating a fairer, more-informative process for startups seeking investment

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          Cro Outsourcing In Clinical Trial

          We are a market research company looking for the following information pertaining to cros on behalf of our client: unique cro outsourcing trends in the clinical trial (cro) industry where cros have been innovative in how they offer services to pharmaceutical companies; real life examples between cros and pharmaceutical companies preferred or approved supplier for major pharmaceutical companies how other pharmaceutical companies validate cro rates without going out to bid? Supplier analysis and market analysis

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            Vijay |Clinical Project Management Consultant

            Hi I have more than 10 years of experience working with pharmaceutical/biotech and medical device ...

            4.5 Hours Later
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            Antonio |Director Laboratory Medical Microbiology

            My experience is limited to Swiss companies CROs....

            5.7 Hours Later
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            Jukka |President, Director

            Hello - I have more than 30 years of experience working with CRO and been on the CRO side as well. M...

            5.7 Hours Later
          +24 Other Responses
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          Benchmarking Practices Within Clinical Trials

          I am looking to get more information on the concept of benchmarking as a practice with a specific focus on how pharma companies are using the practice of benchmarking to identify opportunities within their clinical trial practices, resource management, patient engagement, and portfolio management. I would like an overview on the various kpis / benchmarking parameters considered by pharma for each of the below categories along with case studies, • for an outsourced clinical trial service kpis such as regulatory timelines, patient pool, economic risk rating of country, supplier availability etc., are considered • for recruitment/resource management, we can provide the kpis used in recruitment and management of resources such as attrition, annual turnover, retention rate, co employment risk etc. • for patient engagement, pharma companies are relying on digital platforms to help improve retention (e.G. Ar, vr, gamification and the like and outsource to specialists – paragon solutions). The key parameters considered are therapy, financial assistance, clinical trial participation, patient access and education. • portfolio management benchmarking is key and this is done based on number of compounds, therapeutic areas, stage of development, decision tree analysis etc. Thank you

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