Wednesday, April 9, 2014

CluePoints' Unique Risk-Based Monitoring Technique

Central Statistical Monitoring (CSM) is a key element of the FDA and EMA Regulatory Guidance documents on the subject of Risk-Based Monitoring. The principle of CSM, as defined in the various regulatory guidance documents, is that statistical techniques can be used by Sponsors and CROs to determine the quality and integrity of study data with a view to making better informed decisions regarding monitoring strategy and to ultimately de-risk the study itself.

Last week, CluePoints joined us in Las Vegas at Partnerships in Clinical Trials to share more.  In the following video, like their presentation, they showcase the power of this approach by exploring how they interrogate the entire clinical data set independently and objectively using a comprehensive suite of statistical algorithms to determine exactly where data anomalies are present in centers, regions, countries and subjects. Unlike other Risk-Based Monitoring techniques which depend on a subjective decision regarding the data to analyse and the most appropriate threshold of risk, this approach leaves no stone unturned in assessing data quality, allowing sponsors to target resource on all ‘at risk’ centers quickly and easily. The following video describes how to harness these powerful statistical techniques to improve data quality and reduce cost:

CluePoints - Risk Based Monitoring from CluePoints on Vimeo.

Wednesday, April 2, 2014

The Buzz at #PCTUS: Top Tweets From This Week

This post was written by Mike Madarasz of the Institute for International Research. You can follow him on Twitter at @MikeMadarasz.

Over the course of the last two and half days, there was a great deal of discussion worthy of being shared.  Social media helps to amplify this thought leadership and we'd like to thank everyone for their tweets this week.  Out of nearly 1,000 tweets between 233 participants, we were able to pick six that warrant your attention.  
Big data (AKA "real world data") was a big theme this year.  No surprise there. The fact that it is such a buzzword has diluted some of it's meaning over time.  This week we were reminded again and again that the return on big data comes from the insight it provides and not just the metrics in and of themselves. 

Patient centricity was another topic that was top of mind with many leaders this week.  This idea was one that was met with heavy approval from attendees.  The message here: Clinical trials revolve around patients and in order to be successful, it is the patients that need to be involved.   

Jerry is almost certainly not the only one suffering from some degree of big data "fatigue".  The value is there but the method for extracting that value appears to be something that needs to be addressed on a case-by-case basis.

Another one of everyone's favorite words: Innovate.  That said, this tweet warranted a spot on our list as a gentle reminder.  Thanks for the tweet, MaryAnne.

This was a big takeaway from Roni Zeiger's discussion on patient centricity on day two.  Roni spoke passionately one open lines of communication between doctors and patients as well as giving patients a say in clinical trials.

Deidre BeVard challenged the delegates of the conference to be more social.  There is a lot to be shared and much to be learned at conferences such as Partnerships in Clinical Trials.  Social media provides a medium to expedite this learning process.  That said, we can certainly appreciate where Deidre is coming from.  

#PCTUS: Why Everyone Can Relate When Joe Torre Talks Cancer Survival

This post was written by Mike Madarasz of the Institute for International Research. You can follow him on Twitter at @MikeMadarasz.

From a high level, it may not seem like Baseball Hall of Famer Joe Torre has the ability to connect with a room full of pharmaceutical professionals.  After his keynote to wrap up yesterday at Partnerships in Clinical Trials, it turns out he likely has the ability to connect with a group much more diverse than just pharmaceutical professionals.  The crowd hung on every one of his words for duration of his 53 minute chat with Dr. Amrit Ray.  At the conclusion, it became clear that Mr. Torre may in fact be the perfect to address a room full of people about cancer survival- pharmaceutical professional or not.

Torre and interviewer Amrit Ray , M.D.
of Janssen Pharmceutical Company
Joe can easily relate to the average person
He carries himself like an "average Joe" (no pun intended).  Born in Brooklyn, he conveys a humble demeanor that most people can appreciate.  It's not only the manner in which he speaks, but his character profile as well.  He's famous for having a boss (George Steinbrenner) that was constantly "cracking the whip".  He has an 18 year-old daughter whom he cites as one of the "different worries" he has these days.  He can relate to people on many different levels and that makes him that much more human in addressing something that sometimes transcends that.

He keeps everything in perspective
Baseball took a complete back seat in most of what he spoke about.  Something that resonated with me was the sentiment that since overcoming cancer, "age is just number".  He talked about how when before discovering cancer, turning 60 was the only number that was going to "get his attention".  Now, he speaks about appreciating his days on this earth regardless of age.  This is certainly an admirable attitude for anyone (with or without cancer) and one that a lot of people can associate with. 

For a moment in time, Joe Torre was susceptible 
Cancer is intimidating and overcoming the disease is a monumental achievement.  In talking about his fight, Joe openly admits how scared he was of his diagnosis and how he handled it.  “Information takes a lot of the freight away from cancer" he says.  "Not that it isn’t serious, not that it’s not life-threatening...You want to stay alive and be there for your daughter.”  At this point, Joe was not a baseball Hall of Famer or a Yankee legend.  He was brought to his knees by a powerful illness.  When cancer inevitably does the same to millions more, people can appreciate someone else who can relate.

#PCTUS: 8 Facts from Day 2

Throughout the second day of Partnerships in Clinical Trials, one word was a trending topic throughout the presentations:  communication.   Communication is key among all stakeholders in the clinical trials field to keep trials on a timeline and improve their quality.  We saw an outstanding panel from TransCelerate sharing how they hope to unite the industry and bring changes to build a better industry. Roni Zeiger, MD, Former Chief Health Strategist, Google, and Practicing Urgent Care Physician, CEO, Smart Patients spoke about the patients who are looking to clinical trials for hope and brought a panel of inspiring patients together to talk about how patient involvement could revolutionize the industry.  And we concluded our day with an inspiring conversation between Dr. Amrit Ray  of Janssen and Joe Torre, EVP, Baseball Operations, MLB; Former Manager, New York Yankees about his experience as a patient.

What were some of the thought provoking things we took away from Day 2 at Partnerships in Clinical Trials?
  1. Keynote Roni Zeiger asked: What would co-owning a prescription do for patient when it comes to their health?
  2. Patients don’t view clinical trials as experiments. They view them as treatment options. The industry needs to build feedback loops into the design process so we can get better every time.
  3. Steven Mikita,  Directors, Spinal Muscular Atrophy Foundation, shared that communication is absolutely essential and imperative to move the needle forward for patients. Updates are needed on clinical trial participation and results. Trials can move forward by clinical trial professionals viewing patients as partners.
  4. Jack Whelan, Cancer Warrior & Survivor, ePatient, Clinical Trial Participant shared that patients have two ways to learn about clinical trials. 1) and 2) The form they sign to join the clinical trial. Neither of them present the information in a way that is easily understandable.  How are we working to properly inform patients to about clinical trials?
  5. Susan McHale, Global Senior Director, Clinical Development, Inflammation, Neuroscience and Respiratory Therapy Area, AstraZeneca is in charge of site qualification and training with Transcelerate. The site focused initiative to simply the way they interface with sites. They come forward in putting common forms together. They have a mutual Good Clinical Process process in their training. The minimum criteria is available at this webpage.
  6. When a sponsor company is deciding if they need a CRO partner, sponsor companies should identify what they want your future to look like? What gaps will they have? Can a CRO partner effectively fill the needs of the sponsor company?
  7. Argos Therapeutics shared that as a sponsor, you can’t be afraid to rescue any clinical study. Switch you CRO if you have to. You should have a map for your study but not a solid plan. An communication and flexibility are key throughout it.
  8. To close the day, celebrity keynote speaker Joe Torre, Joe Torre, EVP, Baseball Operations, MLB; Former Manager, New York Yankees; and Cancer Survivor, concluded our day by sharing that anything that is worthwhile will take some time. As a professional in the field of clinical trials, if you save one, that’s important. We are playing the game of life and those in the clinical trials profession are the creating the future of medicine.
Do you have any takeaways you'd like to share from Day 2 at Partnerships in Clinical Trials?

Tuesday, April 1, 2014

#PCTUS: Growing Pains: Outsourcing for Mid-sized Pharma

Today at Partnerships, we have a post from guest blogger Paul Ivsin VP, Consulting Director at CAHG Clinical Trials. He specializes in study enrollment strategies and patient engagement. He writes on clinical trial issues at companion blogs Placebo Lead-In and Placebo Control.

The morning sessions for Partnerships “Strategies for Small to Midsized Pharma and Biotech” track covered three different areas: vendor ID and selection, full-service outsourcing, and site contracting. However, they had a clear unifying theme: standardization and alignment.

This makes sense for midsized companies (and those who aspire to be midsized). Small biotechs can live with a level of chaos is some processes – what they lose in efficiency, they usually more than make up for in nimbleness and flexibility. However, as they grow, the costs of continuously reinventing the wheel start to get prohibitive.

1. Mallinckrodt Pharmaceuticals’ Approach to Vendor ID & Selection: Choosing a Team Rather than a Company
The first presentation, by Bernadette Donohue and Varry Henderson from Mallinckrodt, was a veritable treasure trove of standardization best practices. Donohue started by focusing on the financial health of prospective vendors, and suggested a combination of very specific metrics to look for (book-to-bill ratio and operating income to expense ratio), both as stand-alone indicators of health and as signs of general trends (for example, a company with steady income but mysteriously declining expenses may be looking to make itself more attractive as an acquisition target). She also suggested a thorough review of accessible data from Dunn & Bradstreet reports and SEC filings.

Varry followed by stressing the importance of detailed, well-structured RFP – with the added recommendation of requiring a standardized response from all vendors. Varry also strongly urged sponsors to “not skimp on the bid defense”, allowing a full 3 hours to go through all aspects of the proposed scope of work.

2. Evaluation & Lessons Learned from Year One of Astellas’ Full Sourcing Outsourcing Model for Phase 1 Clinical Trials
The second presentation was jointly given by Astellas’s Edwina Wyatt-Knowles and Rachel Garrido from Parexel, and presented a recap of the first year of their companies’ strategic partnership. Wyatt-Knowles opened by noting that the partnership created its own individual brand (APPEX, short for “Astellas + Parexel Pursuing Excellence”). The intent of the name was to reduce distinctions between the two companies so that all employees felt equally vested in, and responsible for, delivery. She also spoke about the need for clearly defined roles and responsibilities within the team as a key to getting everyone aligned.

Garrido covered the key lessons learned during the first year, which seemed very emblematic of a growing collaboration:

  • ◊ Agree on norms
  • ◊ Create a clear governance structure
  • ◊ Invest in relationship management
  • ◊ Identify relationship inefficiencies
  • ◊ Measure performance

Garrido also emphasized that the metrics collected were not “vendor” metrics, but rather were selected to reflect on the performance of the entire aligned team

Transformation of a Fragmented Site Contract Process into Multi-Partner Collaboration

The third presentation, by UCB’s James Kime and Constance Hopkins, was perhaps the most archtypical of a successful transition from small and chaotic to mid-sized and efficient. Through mergers and growth, UCB found itself with 14 different CROs managing a thousand site contracts, with minimal standardization in how those contracts were written, reviewed, or managed.

The most interesting point of the morning came up when Kime noted that his team initially tried to use a Functional Service Provider (FSP) to handle all contracts on an outsourced basis. However, the team quickly realized that the existing processes were simply too chaotic: successful outsourcing would require a level of organization they hadn’t yet achieved (that’s a remarkable admission, I think, as most sponsors would likely push even harder to outsource a dysfunctional system, so kudos to the UCB team for realizing the only smart move was to build up their internal capabilities).

Hopkins did note that there are still ongoing challenges inherent in their process, including

  • ◊ Turnover at the CRO and sites
  • ◊ Implementation of a Fair Market Value system (especially training sites on how it worked)
  • ◊ Ongoing regulatory change (such as the Sunshine Act)
  • ◊ Increasingly complicated protocols that necessitate custom contracts

However, she noted that even with these challenges, key cycle time metrics had significantly improve (e.g., time to signature was reduced by 36%).

#PCTUS: 8 Cold, Hard Facts From Day 1

This post was authored by Mike Madarasz of the Institute for International Research.  You can follow him on Twitter at @MikeMadarasz

Day one is in the book at Partnerships in Clinical Trials 2014.  A recap would simply not do justice to the depth of knowledge shared throughout the day.  Instead, we pulled eight of the most compelling facts of the day and pondered about their implications on clinical trials.

- 90% of clinical trial patients never find out the result of their clinical trial.  Poor communication with these patients was one of the themes of today.  If doctor's want to earn the trust of their patients, improved lines of communication is one of the first places we can look. 

- Only 27% of Americans can name a living scientist.  The other 73% thought Albert Einstein was still alive.  Just kidding, but this does speak to bleak level of awareness.

- 40% of clinical trial data is fake. Should patients be held accountable here in terms of reporting their data?

- One out of every six drugs will make enough revenue to support the investment.  Could the pharma patent cliff be a first step towards a more even playing field? 

- Half of all sponsors report that they're unable to work collaboratively with CROs.  Some of the methods mentioned today for overcoming this included making an effort to have face-to-face meetings and taking the time to make sure expectations are interpreted clearly.

- China spends roughly 7% of their GDP on healthcare. For the U.S., that number is closer to 18%.   This provides an even bigger incentive for patients in China to participate in clinical trials.

- "Real World Data" is now the preferred vernacular for "Big Data".  It came up several times today.  Is there really a new politically correct term for one of everyone's favorite buzzwords?

- China will be the largest pharmaceutical market in the world by 2020.  It's more of a question of when to invest in China rather then if you should be investing.  Hospital infrastructure and the regulatory environment certainly make it a risk for any company.  However, it appears ready to present an opportunity too great to ignore.

Monday, March 31, 2014

#PCTUS: Top Tweets from Partnerships in Clinical Trials Day 1

We're live from Las Vegas this week at our annual Partnerships in Clinical Trials Conference.  Today was workshop day and we kicked off the morning with Ken Getz, Director, Sponsored Research Programs, Associate Professor, Center for the Study of Drug Development, Tufts University School of Medicine.  And then spent the day in various workshops focusing on clinical trials financing, strategies for small and midsized Pharma and Biotech,  clinical trials in the Asia Pacific region and working with patients in clinical trials.  Tomorrow, we kick off the main session and encourage you to follow along online and join the conversations!  Our official hashtag is #PCTUS.

Here are some of the top tweets from Day 1:

Medikidz Bring First Ever Clinical Trials Graphic Novel to Partnerships 2014

Meet Medikidz CEO Dr. Kim Chilman-Blair at Booth #210 at Partnerships in Clinical Trials This Week!

March 31st, 2014 – New York, NY – Las Vegas, NV – This year’s Partnerships in Clinical Trials Conference is getting an extra dose of superhero action and adventure thanks to the Medikidz, Pump, Axon, Skindy, Chi, and Gastro and their all-new Clinical Trials Graphic Novel! What’s up With Sarah, Medikidz Explain Clinical Trials is a 32-Page full color comic book designed to educate, inform and excite younger patients seeking information on the Clinical Trials process. Attendees of this year’s conference are invited to stop by the Medikidz Booth (#210) for their FREE copy of the new comic along with the chance to meet the Medikidz in-person.

“We are incredibly excited about this book, and the chance to share it with everyone attending Partnerships this year,” said Medikidz CEO and Founder Dr. Kim Chilman-Blair, who will also be in attendance this week What’s up With Sarah, Medikidz Explain Clinical Trials is a fantastic resource for anyone looking for information about the often complex process involved in Clinical Trials in a way that is easy to understand.”

What’s up With Sarah, Medikidz Explain Clinical Trials is one of 65 current Medikidz Graphic Novels designed to breakdown medical information that can often be confusing for patients of any age. To-date Medikidz LTD. has distributed over 4 million copies of their comics around the globe partnering with key opinion leaders in the world of medicine on titles ranging from Type 1 Diabetes to Epilepsy, to create a global community of young people who are informed, empowered and health-aware.

For more information on how What’s up With Sarah, Medikidz Explain Clinical Trials can help explain and boost adherence for Clinical Trials programs worldwide stop by the Medikidz booth (#210) in the Partnerships in Clinical Trials Marketplace this week.

About Medikidz
The Medikidz are five energetic, larger-than-life superheroes on a mission to help young people understand illness and medical concepts. Chi, Pump, Skinderella, Axon and Gastro take children on a journey through Mediland - a planet in outer space shaped just like the human body - to explain the diagnosis, investigation, treatment and prevention of different medical conditions. For more information visit

For Press Inquires Contact:
Kevin Pearl
Medikidz Media & PR

Friday, March 28, 2014

Partnerships One on One: Dr Rabinder Buttar, ClinTec

This week, we got to sit down with Partnerships in Clinical Trials exhibitor ClinTec. Their CEO Dr. Rabinder Buttar President, CEO and Founder of ClinTec International to find out a little more about her company, growth areas and opportunities in the industry as well as their work in emerging markets.

ClinTec International is an exhibitor at Partnerships in Clinical Trials taking place next week in Las Vegas. Would you like to meet them? Stop by their booth in the MarketPlace! As a reader of this blog, you can save $100 off the standard rate when you register to join them and mention code XP1900BLOG.

Have any questions? Email Jennifer Pereira ( We look forward to seeing you next week!

Tuesday, March 25, 2014

Princes and Paupers - Sponsors and patient recruitment vendors trade places

Today at Partnerships, we have a post from guest blogger Paul Ivsin VP, Consulting Director at CAHG Clinical Trials. He specializes in study enrollment strategies and patient engagement. He writes on clinical trial issues at companion blogs Placebo Lead-In and Placebo Control.

"Aren't you tired of not getting the information you need from your recruitment vendor?"

That was the immediate, unhesitating answer I got from Joe Kim at Shire when I asked him what he would say to clinical operations personnel who were considering whether to come to his recruitment vendor relationship workshop.

One day, when we grow up to be sponsors...
As a recruitment vendor myself, it was a hard thing to hear. Even though I've written before about the shortcomings of the clinical trial enrollment enterprise, it's still quite painful when those same thoughts come from a study sponsor.

So I signed up.

Sponsors have all the money,
agencies have all the fun, right?
The workshop is Trading Places Role Reversal Workshop: A Collaborative Approach to Working with Patient Recruitment Partners, and will take place Monday March 31 at the Partnerships in Clinical Trials conference. It is intended to put sponsors and recruitment vendors squarely in each other’s shoes for the afternoon.

“In each other’s shoes” means that yes, there will be role-playing exercises. I’m not a huge fan of role-playing exercises ... who is? (We used to run role-playing exercises during our Patient Recruitment Workshops at IMs. We stopped doing them though, because, well, no one likes doing role-playing exercises.) But Joe and his fellow workshop leaders say it will be fun and enlightening, so I’ll put aside my baggage and trust that it will all work out well.

Trading places: can this vendor be
groomed for pharma-side success?
Joe insisted that the fact that the workshop is being run by 3 sponsors and 0 vendors does not mean the workshop will be biased towards a sponsor perspective. The leaders - Joe, along with Elizabeth Mascherino from Shire and Merck's Kelly McKee, all of whom have had extensive experience working with a variety of recruitment vendors - are only there to facilitate the session, and will not be presenting any particular point of view. “There are plenty of things wrong” with how these programs are managed on the sponsor side, he acknowledged.

But just to be sure, I hereby present some of my personal “What Exactly Were You Thinking?” sponsor highlights:

  • ◊ A study manager who did not want to pay for an advertising campaign still hired us to communicate recruitment “opportunities” to the sites. The low point came when he asked us to talk to a site about participating in an awareness walk in a small city over 100 miles away. Shockingly, the site wasn't big on the idea.
  • ◊ Right in the middle of a highly successful ad campaign (TV and online), senior managers at a sponsor pharma company brought in another vendor to run a direct mail blitz. The study still finished ahead of schedule, but the mail produced no enrollments – I guess it’s good for vendors to have friends in high places.
  • ◊ An RFI for patient recruitment services included a section on certifications which asked whether we were certified Kosher (will we be preparing food for you?) and in “Mil Spec” (That’s a collection of standards, not a single certification. And it’s for military operations.)
  • ◊ One sponsor consistently tried to save money be holding its Investigator Meetings at the old Hyatt on the grounds of DFW airport. “Our sites love it because it’s so easy to get to,” they insisted to me. (Hint: no investigator or coordinator in the history of the known universe has been happy to spend an entire weekend at DFW.)
What are some of the odder behaviors you've encountered in patient recruitment – from either sponsors or vendors? Feel free to share here, or just bring your stories to the workshop. It promises to be an enlightening time, I think.

Partnerships in Clinical Trials is taking place this Sunday, March 30-Wednesday, April 2 in Las Vegas. It's not too late to sign up!  As a reader of this blog, when you register to join us and mention code XP1900BLOG, you'll save $100 off the current rate! Have any questions? Feel free to reach out to Jennifer Pereira.

Friday, March 21, 2014

ActiGraph Introduces Study Admin Portal for Clinical Trials

ActiGraph, a leading provider of objective physical activity and sleep/wake measurement solutions for the global research community, has announced the release of its new Study Admin Portal, a web based software tool that provides the company’s pharmaceutical client base with a turnkey solution for the collection, analysis, and management of actigraphy data as part of a clinical trial protocol.

ActiGraph’s new Study Admin Portal, in conjunction with the company’s newest generation of Bluetooth Smart wireless actigraphy monitors, solves many of the logistical challenges faced by pharmaceutical companies and clinical research organizations seeking to enhance the quality of their trial data through the collection of objective physical activity and sleep measures.

The Study Admin Portal features a simplified ‘plug and play’ actigraphy device deployment and download system to ease operational burden of the clinical team and eliminate the potential for user errors that may result in missing or incomplete data. Once actigraphy monitors are deployed, data can be uploaded directly to the web-based Study Admin Portal via a companion mobile application, giving investigators access to near real time data from anywhere and solving the inherent data collection limitations related to device battery life and data storage capacity. Study coordinators can manage patients site-by-site to ensure that actigraphy data is being captured and there are no issues with devices and wear-compliance.

The Study Admin Portal leverages the power of ActiLife, ActiGraph’s research-driven software platform, to automatically screen collected data and seamlessly deliver patient measures derived from validated, industry standard algorithms to the sponsor or clinical trial database. ActiGraph partners with renowned academic organizations to offer advanced data interpretation services based on specific patient populations, therapeutic areas, or measurement protocols.

“We’ve spent the last decade building hardware and software products to meet the needs of a primarily academic-based research community,” said Jeff Arnett, ActiGraph CEO. “As we’ve become involved in clinical trials over the last several years, we’ve recognized the unique set of challenges these clients face. The Study Admin Portal was developed as a direct response to these challenges and provides our clients with the best of both worlds – high quality, validated objective measures and the simplicity of anautomated, web-based application that can be easily deployed within the complex drug development environment.”

The Study Admin Portal can also be used to augment the functionality of the ActiLife software platform for ActiGraph’s core academic research clients. By linking it with their ActiLife license, researchers can use the Study Admin Portal to efficiently manage studies and access real-time data from the web, while still preserving the ability perform high level analytics on raw subject data using ActiLife.

ActiGraph will be delivering an Innovation Theater presentation in the Partnerships Marketplace at 3:15 pm on Tuesday, April 1, 2014.  Want to join ActiGraph this March 30-April 2 in Las Vegas at Partnerships in Clinical Trials?  As a reader of this blog, when you register to join us and mention code XP1900BLOG, you'll save $100 off current rates!  

About ActiGraph:
ActiGraph’s extensively validated suite of hardware and software products are widely used by prominent scientific and academic organizations in more than 75 countries in research studies and clinical trials involving physical activity, energy expenditure, and sleep/wake behavior and their relationships to a wide range of health conditions including obesity, diabetes, cancer, CNS disorders, cardiovascular disease and sleep disorders. ActiGraph measurement solutions have delivered objective data to many high profile population studies including the National Health and Nutrition Examination Survey (NHANES), the Harvard Women’s Health Study, the German National Cohort, and the U.K. Millennium Cohort Study.

Thursday, March 20, 2014

"Strategic Alignment" a Stumbling Block in Pharma-CRO Alliances

Despite Infrastructure Investment, Implementation Struggle Persists

By Marc Dresner, IIR

Over the last 5-7 years, pharma sponsors and CROs have refined the strategic alliance model to a point where, generally speaking, structuring partnerships is a fairly straightforward endeavor.

The degrees to which they’re being successfully implemented, however, fluctuate fairly wildly.

That’s according to Patty Leuchten, President & CEO of The Avoca Group, which specializes in strategic alliance and relationship management consulting and research for pharmacos, biotechs and CROs.

Patty Leuchten
Avoca Group is celebrating its 15th anniversary this year, so Inside Clinical sat down with Leuchten to discuss the progress the industry has made in strategic alliances and where companies are still struggling.

“The industry as a whole has become really adept at creating a structure for strategic alliances,” said Leuchten, “but there are still significant gaps in their successful implementation.”

Leuchten says most implementation problems center around communication and what Leuchten refers to as “strategic relationship alignment.”

“Ensuring close collaboration and that both sponsor and CRO are deriving significant value from the alliance can be more challenging than developing the strategy, itself.”

“Ensuring that there is close collaboration and that both sponsor and CRO are deriving significant value from the alliance can be more challenging than developing the strategy, itself,” Leuchten told Inside Clinical.

“The tough stuff has to do with implementation and establishing a clear vision for the alliance, effectively communicating that vision with the staff, and implementing a change management approach so that the staff—the personnel on the front lines within the sponsor and the CRO—can live and breathe that vision, and understand specifically their respective roles,” she added.

Not establishing a clear vision, effectively communicating that vision and respective roles with personnel and implementing a change management approach continue to hinder alliance efforts.

In this segments 3-5 of this five-part interview with Inside Clinical—the official podcast series of the 23rdAnnual Partnerships in Clinical Trials conference—Leuchten reviews:

● Key relationship management principles

● Common internal challenges sponsors face

● Best practices for CROs to effectively engage sponsors

These three segments conclude a five-part podcast interview with Patty Leuchten.

Prior episodes may be accessed on the Partnerships in Clinical Trials blog.

To learn about the Avoca Groups 2014 industry research, click here.

To get an update on the latest of partnership guidelines initiative underway at the industry Quality Consortium, click here.

Editor’s note: The Avoca Group will present its 2014 research data for the first time at the 23rd Annual Partnerships in Clinical Trials conference running March 30-April 2 in Las Vegas.  As a reader of this blog, when you register to join us and mention code XP1900BLOG, you can save $100 off the current rate!
For more information or to register, please visit

Marc Dresner is IIR USA's senior editor and special communication projects lead. He is the former executive editor of Pharma Market Research Report, a confidential newsletter for marketing researchers in the pharmaceutical industry. He may be reached at Follow him @mdrezz.

Wednesday, March 19, 2014

Pharma Consortium Preps Clinical Trial Quality Guidelines

Standards for Niche Supplier Pre-Qualification also on Agenda

By Marc Dresner

The Avoca Quality Consortium—comprised of more than 30 pharma, biotech and clinical research companies—is preparing an array of detailed guidelines, tools and templates aimed at standardizing quality management in outsourced clinical trials.

According to Patty Leuchten, president and CEO of the Avoca Group, which founded the industry collaborative in 2012 with sponsors Eli Lilly and Pfizer, the toolbox will build on a framework of eight components developed last year.

The rollout, expected later this year, will be accompanied by a series of educational webinars for each of the respective categories.

Guidelines, tools and templates for eight components of effective quality management will be based on a best practice framework developed last year. 

Patty Leuchten
“We’re designing tools and resources around governance, communication, risk assessment, metrics, oversight, leadership—all of the essentials for proactive quality management and oversight of outsourced clinical trials,” Leuchten told Inside Clinical in a podcast interview.

The Quality Consortium also plans to produce standards for pre-qualifying niche and third-party service providers, a project undertaken at the behest of Consortium members and a much-needed first for the industry, Leuchten noted.

Sponsors and CROs all pre-qualify ancillary suppliers using criteria sufficiently different to create a huge strain.

“Sponsors and CROs all pre-qualify ancillary and niche suppliers using a similar set of criteria, but the criteria are sufficiently different to create a very big strain,” Leuchten said.

“Developing pre-qualification standards will have a huge impact on reducing cost and inefficiency in this space,” she added.

Stay tuned for the final segment of Inside Clinical’s interview with Patty Leuchten, where we’ll really dig into the state of sponsor/CRO strategic partnering, the latest developments and some dramatic trends in this rapidly evolving space!
Editor’s note: The Avoca Group will present its 2014 research data for the first time at the 23rd Annual Partnerships in Clinical Trials conference running March 30-April 2 in Las Vegas.  And as a reader of this blog, when you register to join us and mention code XP1900BLOG, you'll save $100 off the current rate!

For more information or to register, please visit

Marc Dresner
Marc Dresner is IIR USA's senior editor and special communication projects lead. He is the former executive editor of Pharma Market Research Report, a confidential newsletter for marketing researchers in the pharmaceutical industry. He may be reached at Follow him @mdrezz.

Tuesday, March 18, 2014

Gain Buy-In for Change at Your Clinical Organization

Today, we continue our inside look at the Fundamentals of Clinical Outsourcing Certificate Program.  The program will take place March 30-31 at the Mirage in Las Vegas, Nevada.  This program is designed to help you create your outsourcing strategy and choose a model for your outsourced project and organization.

Today, we look at the presentation from Gregory Whelan, J.D., the Director, Outsourcing Lead, Business Operations at Pfizer, Inc.

Session Title: Gain Buy-In for Change

About the session: You’ve got your clinical outsourcing and category strategy nailed down and now it’s time for your organization to move forward as a more efficient R&D machine. But, how do you get the other team members to buy-in to the notion of change? This session combines case study lessons learned, effective communication skills and tactics to connect the interorganizational dots to show you the way to gaining internal buy-in.

For more information on the rest of the program, download the agenda.  The event will take place March 30-31 in Las Vegas.  As a reader of this blog, when you register and mention priority code XP1901BLOG, you can save $100 off the current rate!

Big Pharma, CROs Tackle Big Data for Clinical Trials

Study Explores How Sponsor/CRO Partnerships Optimize Clinical Trials

By Marc Dresner, IIR

In just a couple of weeks the Avoca Group will present the findings from its highly anticipated annual study on sponsor/CRO partnering at the 23rd Annual Partnerships in Clinical Trials.

Inside Clinical sat down with Avoca Group President & CEO Patty Leuchten for a sneak peak.

This year’s Avoca Group industry survey focuses on clinical trial optimization, Leuchten reported.

“We’re doing a deep dive into whether strategic partnerships are contributing to more intelligent approaches to clinical trial planning and execution,” she said.

The forthcoming report will cover how well current partnership models lend themselves to producing innovative solutions

The forthcoming report will cover how well current partnership models lend themselves to producing innovative solutions, particularly those that apply data—operational or clinical—to optimize protocol design, investigator selection, patient recruitment, risk assessment, resource allocation, etc.
Patty Leuchten

Perhaps not surprisingly, Leuchten reports sponsors and CROs are still struggling to wrap their brains around Big Data and its potential role in trial optimization.

Companies are just beginning to think about the concept of Big Data and how to harness and leverage this information for making decisions about clinical trial planning,” Leuchten told Inside Clinical.

“Other industries are much farther along, in terms of leveraging information to make decisions and to take action and using Big Data as triggers,” she said.
“There is a real opportunity for sponsors engage CROs much earlier in the clinical trial planning process.”

Operating in siloes has been a perennial partnering challenge, particularly when it comes to developing innovative solutions.
So, the study will also provide a read on the degree to which sponsors and CROs are collaborating on Big Data and other joint, innovative solutions.

“I think there is a real opportunity for sponsors to engage their CRO partners much earlier in clinical trial planning process and in actually working with the CRO to leverage all this information and data to make better decisions,” said Leuchten.

Stay tuned for Part II of Inside Clinical’s interview with Patty Leuchten for an update on the Avoca Quality Consortium and its work on streamlining niche and third-party supplier selection!
Editor’s note: The Avoca Group will present its 2014 research data for the first time at the 23rd Annual Partnerships in Clinical Trials conference running March 30-April 2 in Las Vegas.
For more information or to register, please visit

Marc Dresner
Marc Dresner is IIR USA's senior editor and special communication projects lead. He is the former executive editor of Pharma Market Research Report, a confidential newsletter for marketing researchers in the pharmaceutical industry. He may be reached at Follow him @mdrezz