Vetting partners. Contract negotiations. CRO monitoring and audits. Delays, overruns, and quality issues.
If your clinical trial strategy involves outsourcing, you’ll face unique challenges that arise when coordinating your trial through a third-party.
Clinical Leader Forum is all about sponsor-CRO partnerships and the issues that matter most
to executives at small and mid-sized sponsor companies (or anyone who outsources).
With limitless CROs to evaluate, how do you find the right match? Ask questions of other sponsors about their strategies for selecting outsourcing partners for trials.
What is a performance scorecard and how do you use it? Learn methods to assess your CRO and how to get the most out of your sites and CRAs.
How can you meet the FDA’s demands for a diversified patient pool? Find out what the FDA requires of trial sponsors and how you can exceed expectations.
May 10-11 at the Hilton City center in Philadelphia
We'd only ask you to attend a meeting we'd actually want to attend. For us, that means it must be inviting, high-energy, and incredibly helpful. Here’s what makes the Clinical Leader Forum worth attending:
Tailored just for executives at sponsor companies that rely on CROs for clinical trials
12 sessions loaded with takeaways to improve your outsourced trial outcomes
25+ speakers with real experience at small, mid-sized, and large sponsor companies
Keynote on the controversial rise and fall of Scios and its heart failure drug, Nesiritide
Intimate exhibition space for meeting-and-greeting 30+ potential CRO partners
7+ hours of networking to connect with others who are struggling with your challenges
Located in Philadelphia for quick and convenient travel from nearby pharma hubs
7:00AM - 9:00AM
9:00AM - 9:15AM
9:15AM - 10:00AM
With thousands of CROs to choose from, how do you find the one that is right for you? Learn proven strategies for making the right choice, including preparing a list of candidates, vetting techniques, evaluating vendor presentations, and conducting effective site visits .
10:00AM - 10:45AM
10:45AM - 11:20AM
There are concrete methods to determine if your CRO is on track and leading your clinical trial to a successful conclusion. Discover the best ways to evaluate your CRO’s performance as measured by quality, regulatory, timeliness, and other factors.
11:25AM - 12:00PM
How do you handle the cost increases related to a protocol change? Session takeaways include effectively managing change orders, communicating change orders, strategies for avoiding change orders, defining change order types, and proper designation of change order cost.
1:15PM - 1:50PM
Sites often place too much attention on large pharma clients and CROs at the expense of smaller pharma companies. Learn strategies to monitor your partner, including site monitoring tactics, monitoring CRA performance, and improving connections with sites and CRAs.
1:55PM - 2:30PM
Get advice for auditing your CROs and your trial, including answers to questions like: Is the data being collected according to protocol? Can you ensure the data is accurate? What’s the best way to view the data without being overwhelmed? How should you begin to analyze the data?
2:30PM - 3:15PM
3:15PM - 4:00PM
This lively, moderated debate between a sponsor and CRO will help you understand how common problems occur, the best ways to quickly resolve them, and methods to ensure they don’t happen again.
4:00PM - 6:00PM
Dr. Roger Mill’s book, Nesiritide – The Rise and Fall of Scios, details his experiences at Scios as VP of Medical Affairs during the company’s attempt to bring the heart failure drug Nesiritide to market after claims it might cause kidney failure and death. Dr. Mills will discuss mistakes made along the way, what could have been done differently, and what you can learn from his experience.
Despite the best plans, sometimes a trial veers off course. Learn how to determine if your study needs rescued, what team is responsible for study rescue, when to rescue (and when to bail out), and who to turn to when all else fails.
The FDA is demanding clinical trials represent a wider spectrum of patients. Sponsors are struggling to meet this requirement. Find out what the FDA is actually asking of clinical trial sponsors and discover techniques that will diversify your pool of trial participants.
You may not be an expert at negotiating contracts, but you need to be able to put a correct valuation on your trial. Hear strategies to determine pricing factors for your trial, whether fixed-versus-variable pricing is best for you, and how to avoid getting nickel-and-dimed by your partner.
True centricity involves hearing the voice of the patient and getting it involved in your trial design. Doing so will allow you to design trials that are friendly to patients and sites, while allowing you to improve recruitment and retention. Learn how others sponsors are successfully making patient centricity a reality.
Wearables, social media, adaptive trials, risk-based monitoring, eTechnologies, big data, and electronic health records. What do these transformative technologies mean for small- and mid-sized pharma companies? Understand the innovations that will determine your trial’s success in the future.
For end-users to the pharma industry (sponsors with pipelines, consultants). Full program.
Rate expires March 1.
For end-users to the pharma industry (sponsors with pipelines, consultants).Full program.
Rate valid for teams of 2+.
Passes to the Clinical Leader Forum in Philadelphia are all inclusive - conference sessions, exhibit hall access, and networking are included. The program is fully catered with an exceptional spread.
To reserve an industry pass, your company must be an end-user to the pharma industry. We define end-users as pharma/biopharma companies, biotechs, and consultants. We will decline all registrations that do not meet this criteria.
Service providers that wish to attend should contact us for details on sponsorships.