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!
+11 Other ResponsesSystematic Reviewing And Health Technology Assessment
We need an expert in systematic review, health technology assessment, and meta-analyses. We are on very tight schedule in submitting this grant within 5 days from november 91th, 2011. Please contact me asap. The project is on going and will required 3-4 systematic reviewing per year.
Sorry for the short notice.
Thanks,
dzuy
+17 Other ResponsesCro 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
+24 Other ResponsesClinical Trial
Currently i am doing a research on rx to otc switch clinical trials.
I request you to provide some insights on rx to otc switch actual use clinical trial market ( market size and region wise split) and supplier market(pricing models for these trials, how these trials are conducted in different regions, drivers and constraints for these trials in different regions, who are the suppliers/cro for these trials in different regions).
+9 Other ResponsesClinical Research
Looking for subject matter experts / consultants in clinical research, clinical trial, risk management, audit and inspection, gcp, clinical outsourcing, trial design and management,ethics fraud and misconduct, patient recruitment , documentation and management, clinical laboratories, facility/hospital , hospital clinical compliance, billing and coding for clinical services , patient/third-party coding and billing, sponsors, cros, clinical quality control/cqc for speaking engagements with over 25+ years of experience. Feel free to reach out to me.
+20 Other ResponsesClinical 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
+24 Other ResponsesClinical 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.
+54 Other ResponsesClinical Research Regulatory Service
• study objective:
to assess the clinical research consulting space with special emphasis on independent review board (irb) services. The aim is to understand the dynamics in the service/product offerings (regulatory compliance, medical writing, strategic affairs, electronic consent manager, meeting scheduler etc.). In addition, we would also like to understand the market overview of irb services comprising of market size, recent trends, drivers, barriers, etc. Focus would be to understand the customer needs, competitive landscape, pricing and market landscape for irb consulting services (regulatory compliance, medical writing, strategic affairs etc.).
• following are some of the key questions:
o what are the different services offered under regulatory consulting in clinical research?
O who are the key users / customers of regulatory consulting services?
O what are the needs for these services of different customers
o what are the factors that influence the customer’s purchase decision of consulting services / products?
O who are the top players providing consulting services and what is their market share?
O what are the billable rates charged on an hourly basis by the companies?
O why, if at all, do the rates differ across various services?
O are there different rates for different customer types? What are the reasons?
O how is the pricing structured for software products such as electronic consent form, meeting scheduler etc.?
o what are the key market trends, growth drivers and barriers to growth etc.?
o where are the key opportunities within the regulatory consulting market?
Preferred expert should meet the following criteria:
o location: us
o industry experience of 15+ years in the clinical research industry
o worked in coordinating clinical trials, device trails and observational studies, regulatory & irb submission, recruitment, data collection and input, source documentation creation, and overseeing good clinical practices (gcp) and ich guidelines
o understanding of clinical studies to ensure compliance with ich/gcp guidelines and federal regulations
o knowledge of regulatory consulting services as well as software offerings specific to clinical trial / research
o understanding of purchase process and pricing structure of consulting services
+12 Other ResponsesSaas 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.
+undefined Other ResponsesMeta Analysis
I have a need of an experienced statistician to help me with meta analysis of observational studies in health. I can offer co-authorship for the paper. I have selected the studies that need to be included and need to enter the data. This is where i need help.
Cheers
+undefined Other ResponsesClinical 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
+undefined Other ResponsesClinical Trial Compliance
Looking for consultants on areas like clinical trial compliance with 20+ years experience. To know more feel free to contact me.
+16 Other Responses
