Insights from the Outsourcing in Clinical Trials Europe Conference

By Kristy Anderson, Project Manager

The 3rd Annual Outsourcing in Clinical Trials Europe Conference in Zurich, Switzerland turned out to be much more compelling than I ever anticipated. The two day event, held on May 14 -15, enabled me to mingle and meet with various industry professionals from Sponsors, to CROs, and other vendors like Bracket. I particularly enjoyed being in the company of so many brilliant minds that had come together with the common goal of helping to improve the lives of those suffering with illnesses throughout the world.

Armed with an iPhone and Twitter account, I made notes of the two days the 21st century way – I tweeted my favorite pieces from the sessions, which enabled me share the wisdom with the world (okay only my 51 followers and whoever else happened to be following #OCTEurope!). By far, one of my favorite speeches was on day 2, given by Michael Zöher from AOP Pharmaceuticals. His morning talk awoke the crowd from their sleepiness and had everyone in stitches while he likened communications between Sponsors and vendors as sometimes a tug boat pulling an ocean liner or a Wild, Wild West face-off between Dirty Harry and the poor schmuck to taste his bullet! But what he said was true: communication is the key to a successful relationship – for whoever is involved in the study! Without good communications, things can quickly turn into the face-off scene from Dirty Harry, and from that, it is difficult for any company to recover and have a good rapport again.

During a panel discussion with Elke Bestel (PregLem), Peter Clompen (Actelion Pharma) and Annika Elelöw (Swedish Orphan Biovitrum), they spoke on how crucial excellent project management is to running a successful study. It was also suggested, and agreed by many, that the PM who will take on the study, if won, should be present at the bid defense and assume a very active role in winning the business. Sales team: hook us up! PM team: get your passports ready!

The panel also discussed the fact that while the Sponsors are in the age of trying to cut some budgets to these very costly trials, there are some things that should not be cut. Ever. Face to face meetings are usually the first to go; however, meeting with your Project Manager regularly is important, and the speaker counseled the room that if the budget needs to be cut somewhere, never take it from the F2F meetings.

For all the “stats geeks” out there reading this ditty: nearly 80% of all clinical trials fail to meet enrollment timelines; up to 50% of research sites enroll only 1 or no patients; 20% of investigators do not enroll any patients; and a Jack Daniels and Coke costs nearly 20 Swiss francs!

In all, I’m really glad that I had the opportunity to attend (thanks to my colleagues, Brian and Shannon, for pulling out at the last minute!) as I learned a mountain of information. This conference helped me see things from the perspective of the Sponsor side and how they feel about the work that we do for them.

Thomas Jefferson – “Whenever you do a thing, act as if all the world were watching.”

Bracket Sponsors Silicon Valley Fundraiser

By Jen Burstedt, Marketing & Communications

Dharmesh Shah, Product Development Team Lead at Bracket, spends his day job managing a talented team of software developers who develop a framework to build custom software used to conduct clinical trials (interactive voice response/web response systems).

As an employee with a global perspective, Dharmesh wanted to give back in a global way – and so he got involved with a local non-profit organization called Vibha (a local branch of the non-profit organization “Help Them Grow, Inc.”) Vibha aims to support education, health, and opportunity for underprivileged children in India and in the US through donating funds to select local grassroot efforts.

On Sunday, June 2nd, the organization is hosting a 5k/10k/half marathon in San Jose, California. Dharmesh is the Event Lead and is the individual overseeing all the moving parts for this huge fundraiser, who estimates to bring out 1,500 runners and 600 spectators from the local community to San Jose for the event.

Says Dharmesh of this event, “most of us lead privileged lives and get numerous opportunities to fulfill the purpose of our existence, but the realities for millions of people all around the world are very bleak. So this year, I am participating in the Dream Mile, Vibha’s signature Half-Marathon/5K/10K event to raise awareness about the plight of underprivileged children in the U.S. and India. Join me with 1500 other runners on our mission, and make a difference.”

More information on the event can be found on The Dream Mile’s website: http://thedreammile.org/bayarea

To donate to the cause, link to Dharmesh’s page for the event: http://www.active.com/donate/DMBayarea2013/be_the_change

Feel free to email Jen Burstedt at jen [dot] Burstedt [at] bracketglobal [dot] com with further questions or comments.

Top 10 Proposal Questions to Ask In A Clinical IxRS RFP

By Jen Burstedt, Marketing & Communications

As I started my career in the proposals department at Bracket, I have read through my fair share of protocols and Request for Proposals (RFPs), digging through these documents for information relevant toward writing a proposal and putting together the budget for Interactive Web (or Voice) Response Systems (IWRS/IVRS – or IxRS, as it will be referred here) for clinical trials from Phase I – IV.

There are massive amounts of variation from the RFPs sent it – some proposals which ask very few questions; others include 80 questions in addition to the actual proposal and budget.

This top 10 list will be helpful if you:

  • Have been tasked with creating an RFP to send to potential IxRS vendors
  • Are curious if there are any key questions you might be omitting in your RFP process

Here are the top 10 questions we feel are the most important to include in your RFP to IxRS vendors. Of course, we haven’t included therapeutic area or study-specific questions. This top 10 list is meant to make sure you have included the most important ones.

  1. Vendor Governance: what is the internal management structure of sponsor aligned teams? How will these teams support quality?
  2. Research and Development: define your three year plan, your new technologies and the direction you see the industry going.
  3. Integrations: define your IxRS’s integration capabilities and experience with specific systems.
  4. Incident Reporting and CAPA: define channel(s) for communication and escalation process (internal and external), as well as the procedures and processes in place to support issue identification, resolution, reporting and corrective and preventive actions (CAPA).
  5. Infrastructure: define the validation of your platform.
  6. Business Continuity & Disaster Recovery Plans: define these plans.
  7. Security: define your security measures, and what this means regarding employee building and network access. Additionally, address user access to the system. What, if any, restrictions are there in place based on user roles?
  8. Audit Trails and Data Change Process: define the audit trail in place and the Data Change process in place.
  9. Change Control Process: define this process.
  10. Development of Standards: if you are have worked with this vendor before, is there a potential to develop standards for your studies – either on a program of studies or across all studies? a. How would the development of these standards impact pricing, timelines and quality processes? b. Define potential efficiencies linked to volume and re-use. c. Define the Project Lifecycle (PLC, including design, code and testing of requirements for custom and standard functionality).

Whether asked of new IxRS vendors or with familiar vendors, this is a starting point to give you context, insight and a general feeling of a vendor, which – along with the pricing and actual proposal – can help. you to decide if the relationship will be one that is a mutual fit between your organization and the IxRS vendor.

Feel free to email Jen Burstedt at jen [dot] Burstedt [at] bracketglobal [dot] com with further questions or comments.

Thank you to Brian Parks, Senior Director, Proposals, for giving insight through providing this top 10 list.

Business Spotlight: Spring Cleaning Your Email

By Cheryl Selleny, Marketing & Communications

There is no escaping your emails, especially now with smartphones. For many of us, it is the main form of communication for our professional, as well as personal life. Busy schedules and different time zones contribute to the fact that sometimes it’s just easier to email someone. As a result, you are probably spending countless hours on email during the work day. Does this bite into your productivity? Most likely, it does.

Wouldn’t it be glorious to just delete all of those unread emails and start from a clean slate? It would be very cleansing, but probably not the smartest career move. Ignoring them is another option, but be prepared to have many frustrated, answer-seeking warriors hunting you down. The optimal solution is to take control of your email and get more accomplished.

The ideal scenario is to have only three emails in your Inbox at one time. I can hear you laughing out loud at this point, but it is possible! As soon as you read an email, the key is to do something with that email. Trash the junk mail, respond immediately to the emails that you can and create a task for those you need more time to think about. By creating tasks, you’ve designated a time to concentrate on that specific email. Most email clients enable you to create tasks and there are also countless project management tools that can assist you. Saving the email in the task you’ve created clears it from your Inbox and tucks it away in a spot where you can create reminders to pay attention to it at a later time. Rereading the same emails over and over again is another substantial time snatcher; this method will free you from falling into that trap. As a result, you will begin to feel less stressed and more able to get your work done.

Michael Linenberger’s book Total Workday Control goes into much more detail about how to control your email and get more done. The concept is simple, but the results will be a dramatic increase in productivity and work day control.

Bracket Encourages Its Employees To Get Involved

By Chris Talbot, HR Manager, Europe and Claire Ward, Project Specialist, Goring

Bracket is proud to encourage and support its employees to get involved in fundraising events that benefit their local or national charities. Bracket provides each of our global offices with a donation to be contributed to a charitable organization of their choosing. Bracket UK have set themselves two grueling challenges in aid of British Heart Foundation and Cancer Research UK .

A group of employees from both the Goring and Hammersmith office embarked on the first of two planned charitable events this year, the London to Reading Bike Ride. The event, which aided the British Heart Foundation, took place on April 28th, 2013 and involved cycling 40 miles from London to Reading. The British Heart Foundation funds research into the causes, diagnosis, treatment and prevention of heart and circulatory disease.

 

BracketCharityBikeRide_lores_0Not satisfied with just cycling 40 miles, the team will set out to conquer Mount Snowdon on July 27th, 2013 in aid of Cancer Research UK. Snowdon is the largest mountain in Wales, standing roughly 1085m above sea level, which should take the team between 6-8 hours to complete the climb. Cancer Research UK is the leading cancer research and awareness charity in the United Kingdom. As the world’s largest independent cancer research charity it conducts research into the prevention, diagnosis and treatment of the disease.

We have chosen Cancer Research in memory of a former employee and dear friend, Gretchen Amorim who passed away last year. Gretchen had worked in the Goring office for over 3 years but had made many friends all over Bracket. Gretchen battled with cancer a number of times before she sadly passed away, her bravery was an inspiration to everyone.

Show your support: https://www.justgiving.com/BracketMountainClimb

Bracket at the BNA 2013: Festival of Neuroscience, London

By Professor Keith Wesnes, BSc, PhD, FSS, Cpsychol, FBPsS

The British Neuroscience Association’s biennial meeting in 2013 involved 18 learned societies with neuroscience interests who contributed symposia to the programme, creating a meeting with 56 scientific sessions and 7 plenary lectures involving more than 240 speakers, over 80 from outside the U.K. I presented four papers on the contribution of Bracket’s proprietary CDR System to current research in cognitive neuroscience, including: a review of the system’s unique record in detecting cognition enhancement in volunteers and over 30 clinical conditions; the development and validation of the platform for administering the system via the internet; and the latest exciting developments with a CDR System task which can detect changes in the activity of the hippocampal dentate gyrus, one of the two brain regions responsible for neurogenesis in man.

Click on the links below to view the posters:

An Instrument for Conducting Cognitive Testing via the Internet 

Human Hippocampal Neurogenesis Assessed by Object Pattern Recognition: In Which Clinical Conditions is the Dentate Gyrus Functioning Normally?

Are Traditional Neuropsychological Tests When Administered Repeatedly Suitable for Assessing Therapeutic Benefits to Cognitive Function in Clinical Trials?

A Review of 187 Clinical Trials of Cognition Enhancement Using a Single Computerized System Designed Specifically for Clinical Neuroscience