Clinical Research - Negotiation of Contracts and Budgets for Sites

Clinical Research - Negotiation of Contracts and Budgets for Sites Contact information, map and directions, contact form, opening hours, services, ratings, photos, videos and announcements from Clinical Research - Negotiation of Contracts and Budgets for Sites, Medical Research Center, San Diego, CA.

03/28/2019

Statistics You Need to Think About


Statistics show the number of P*s falling out of research after one trial is 54%. The pool of experienced P*s is shrinking by 3% per year. You may say this is due to inexperience, but the results of research done by Tufts and Duke show that the reasons are the same frustrations you deal with every day at your site.
Trial design is becoming more complicated: a Ph 3 protocol has had a 60% increase in the number of procedures required since 2000. Tufts stated "compared to 10 years ago, protocols have more endpoints, procedures, eligibility criteria, CRF pages, amendments". More work is being required by sponsors to the site, greater regulatory issues, and the ongoing issues of financial viability at the sites .
Top 4 needs:
1) Developing site research infrastructure and staff
2) Optimizing trial ex*****on/conduct
3) Improving site budget/contract negotiations
4) Additional trials to conduct
If I can help you with #1 (utilizing some outsourced services), I can handle #3 myself, and #4 - I can direct you to a great Business Development resource – that leaves you “free” to handle #2 yourself, which would really result in “optimizing” your trial ex*****on! Why would you not address these opportunities?
46% of investigators report being unsatisfied with finance issues:
• The complex reimbursement process for the costs of clinical trials.
• The high level of administrative overhead — paperwork, regulatory, and IT — associated with running clinical trials. This overhead usually exceeds the expectations and budget, resulting is inadequate resourcing, and thus being stuck with a bad deal.
• Study budgets are flat while procedures per subject are increasing. Sites have seen increases in paperwork, protocol complexity, challenges with patient recruitment, mgmt and performance metrics, patient screening and informed consent complexity, site staff GCP/IT training and compliance requirements. BUT, Site budgets, have not increased to address this added overhead.
• Not addressing any annual inflation adjustments, ignoring the fact a site’s expenses across the board are constantly increasing.
• Slow payment process: The studies show that it takes between 122 and 140 days from a patient visit for a site to receive payment (number of days depends on whether from a pharma company or a CRO), greatly affecting a site’s cash flow.
If I can help you with these issues, why would you not address this opportunity? Contact me for assistance!

03/11/2019

FAIR MARKET VALUE





Don’t you hate to hear that term from a Sponsor/CRO during negotiations?

Every Sponsor/CRO company varies when it comes to “creating” FMV for a specific trial. The actual definition of FMV is subjective and not easy to apply consistently. There are not specific numbers for acceptable fees. This results in no one having accurate information to calculate FMV. The entire cost of a trial is the responsibility of the Sponsor. They do not handle day-to-day issues, yet they create the budgets for the day-to-day operation at research sites. There are companies that offer benchmark “tools”, yet even Medicare is associated with errors in pricing and these benchmark “tools” may not match up to so many issues specific to any individual site at any various time, trial, or indication.

Do you have the time to be familiar with all of “your” specific FMV fees for each of your trials? How do you deal with the FMV issue? You hire a person with specific expertise in the budget negotiation process. Robbin Hansen - Please contact me for more information on how I can help you with the entire budget and contract process.

03/01/2019

Outsourcing Contract/Budget Negotiations

In my network, I have experts for processes every site needs to be successful. Business Development - new trials, billing/collections/data entry, regulatory and, of course, my own services of negotiating your contracts and budgets between the sponsor/CRO and your site.

When you have a family member in need of care, it quickly becomes overwhelming, stressful and will cause serious burnout. You don't hesitate to get more/better care than you can give, you don't hesitate to gather information and professional caregivers to make sure your family member has the best quality of life you can give to them. Once in place, you can rest easy knowing you did your best and that all of their needs will be met.

Your site IS your family member, your loved one. Avoid the stress and burnout. Don't hesitate to contact an expert “caregiver” for the negotiation of contracts and budgets. Don't hesitate to contact me for information on giving your site the best “caregiver” so that your site can live a full, successful, profitable life. You can then rest easy knowing that you made the perfect decision and that your site is fully taken care of in the best, most timely and efficient manner.

02/21/2019

CLINICAL RESEARCH CONTRACT AND BUDGET NEGOTIATIONS

ROBBIN HANSEN, CRCP

“Expertise in the Clinical Trials industry is a rare commodity and when you find such a person, who works well with you, Treasure Your Good Fortune.”
Researchroundtable.com
___________________________________________________________________________________________
Robbin has over 16 years of experience in negotiating both clinical trial agreements and study budgets for clinical trials. She has worked on both sides of the negotiating table – for sites and for a CRO. This gives her a unique perspective and insight into the process.
Her first objective is to ensure that sites are paid for all procedures outlined in the protocol, not all of which are included in the budget grid. When the budget is sent as a visit only rate, Robbin will build a study budget grid to ensure that all procedures are included. Her experience working with multiple sites and sponsors keeps her current on procedure rates and site fees.
Robbin also emphasizes protecting your site by negotiating you away from potential legal traps to that of a more balanced position. While she does not provide legal advice or counsel, she has in-depth knowledge of CTA language and how best to protect sites.
Robbin’s specialized expertise provides fast and efficient turnaround of documents, eliminating delays in start of enrollment. CRO’s appreciate a quick turn-around! Her services save sites time and money by outsourcing this entire process, allowing the staff to concentrate on managing your clinical trials.
Robbin has the ability to support Phase II to Phase IV research programs covering a wide range of medical and psychiatric indications. She has worked with most major Sponsors and CROs.

02/21/2019

Negotiating Clinical Research Contracts and Budgets

Most sites don't have a person with this specialized expertise and most sites don’t have a person with the time to devote to this process. I have 17 years of experience negotiating from the site perspective and time with a CRO. Outsource this process, I can help! Outsourcing can save you time and money! This is not just for newer, smaller sites, but also a key component to busy larger sites.
Trials are becoming more complex, sponsors are wanting more from the sites.
Study Coordinator turnover is high and to have a coordinator know enough about the site’s financial info to negotiate a profitable/complete budget is not often a wise decision.
Good feasibility analysis to make good trial choices is key to becoming a great site, not just ask “do we have enough patients to meet the goal?” Then to have your valuable time be taken up with negotiating the contract and budget? Give that to a person with this specialized skill set so that you can use YOUR specialized experience and time managing your trials.
Apply your time and your experience directly to the good trial choice you made. See my bio attached. Contact me for more information on how I can help.

Address

San Diego, CA

Telephone

+16194468431

Website

Alerts

Be the first to know and let us send you an email when Clinical Research - Negotiation of Contracts and Budgets for Sites posts news and promotions. Your email address will not be used for any other purpose, and you can unsubscribe at any time.

Shortcuts

Share

Share on Facebook Share on Twitter Share on LinkedIn
Share on Pinterest Share on Reddit Share via Email
Share on WhatsApp Share on Instagram Share on Telegram

Category