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CRUCIAL CBC Services Overview June09
1.
SOLVING THE CLINICAL
PUZZLE www.crucialcbc.com Confidential. © CRUCIAL Clinical/Business Consultants. All rights reserved.
2.
WHAT WE DO
CRUCIAL matches best-of-breed clinical providers with Sponsors’ specific needs Increases success probability of the project Decreases time spent sourcing providers Decreases time spent in evaluation and assessment Increases productivity Confidential. © CRUCIAL Clinical/Business Consultants. All rights reserved.
3.
HOW WE DO
IT CRUCIAL has a broad network of connections across the industry We maintain a portfolio of pre-qualified Affiliates in EDC, CTMS, ePRO, IVRS, Monitoring, CENTRAL IRBs, BioStats, Animal Labs, QA, Specialized CROs and more Each Affiliate undergoes a comprehensive qualification process generally taking at least 20-30 hours We choose to work with fewer than 1 in 3 who seek us out Confidential. © CRUCIAL Clinical/Business Consultants. All rights reserved.
4.
HOW WE DO
IT CONT. Our process includes the following: Assessment of work samples (repeated technology demos or written as applicable) Provider completion of 17 page in-depth assessment tool Interview by CRUCIAL using assessment tool as foundation Provider Customer Completion of 5 page questionnaire Not less than 3, ideally >5, randomly selected customer references Interview by CRUCIAL of customer references post questionnaire completion Research of company using industry relationships, internet tools, Life Science specific databases Confidential. © CRUCIAL Clinical/Business Consultants. All rights reserved.
5.
WHAT WE’RE LOOKING
FOR Quality/Compliance Experience Reliability Stability Unique skill-set/product Pricing model Ability to interface effectively with other providers Confidential. © CRUCIAL Clinical/Business Consultants. All rights reserved.
6.
OUR PROMISE TO
YOU We will always... Act with the highest degree of professionalism and honesty Work diligently to understand your unique needs Be responsive, and treat your time with the respect it deserves Match your needs with the best provider - and if they don’t match with any of our pre-qualified providers, we’ll tell you Stay involved after your project gets underway to ensure you are getting the services you expect from the providers we recommend Confidential. © CRUCIAL Clinical/Business Consultants. All rights reserved.
7.
OUR PROMISE TO
YOU CONT. We will never... Recommend a provider with a poor fit for your needs - not for money, not for quid pro quo’s, not for anything: your success is paramount to you, and to us Tell you a provider can perform a service/deliver a particular product when we know otherwise Recommend a provider simply on the basis of payment for our services - we only recommend providers on their ability to meet your needs effectively Confidential. © CRUCIAL Clinical/Business Consultants. All rights reserved.
8.
WHY YOU SHOULD
WORK WITH CRUCIAL Simple. We save you time, money and stress in sourcing the very best providers for your clinical research needs. We have access to specialist providers most companies aren’t aware of We are experts in clinical support technologies and service providers We know the right questions to ask (and what the answers should be!) We give you unbiased, independent, crucial information unavailable by any other method Confidential. © CRUCIAL Clinical/Business Consultants. All rights reserved.
9.
VALUE ADDED DIRECT
CRUCIAL SERVICES Whether you need assistance, or even just another set of eyes and opinion, CRUCIAL delivers comprehensive concrete action plans in - Technology Implementation Clinical Operations Site and Investigator Training Clinical Product Strategy Patient Information Materials White Paper Authoring Contracts & related Negotiations PowerPoint Presentation Website/Internet Development Presence/Promotion/Recruitment Confidential. © CRUCIAL Clinical/Business Consultants. All rights reserved.
10.
TESTIMONIALS “There's a depth
of understanding there that's almost scary. Very few others I've met in the 10 years since I first started working with the CRUCIAL Principals have the same understanding of the clinical process…I have no hesitation in recommending them to anyone needing clinical support services, especially on the technology side.quot; Tom Grooms, Vice President Information Technology Asia-Pacific, Medtronic Inc. “I am quite pleased to have had the opportunity to collaborate over the years with the CRUCIAL Principals on a number of complex clinical study projects and will look forward to once again. I have found their thorough knowledge and understanding of e-Clinical and e-Technology to be invaluable. …Highly recommended.” David Luster, Director, Abt BioPharma Solutions quot;I was expecting just another clinical consultant, but what we got was quite different. I was pleasantly surprised at the depth and breadth of CRUCIAL's knowledge across critical areas of the business from clinical operations and staffing, to product development and marketing; web-based trial recruitment techniques, through technology assessment and training - the speed and quality of the work was such I'd call them again in a heartbeat next time.” Steve Anderson, President, Acorn Cardiovascular Confidential. © CRUCIAL Clinical/Business Consultants. All rights reserved.
11.
OUR PRINCIPALS Dr Timothy
Pratt PhD Dr Pratt is a well-known figure in the Life Sciences clinical industry, and was voted to the top 100 “most inspiring in Life Sciences” by PharmaVOICE readers in 2005. A prolific publisher and speaker, Dr Pratt leverages clinical research and business experiences gained over 20 years and countries such as Australia, Canada, the UK, the USA, France, Holland, Germany, Italy, Spain and others. His Life Sciences focused education which includes a PhD, 3 Master’s degrees, and a number of specialist post-graduate qualifications complement an enviable history as a clinician and helps him provide unique and penetrating insights into efficiency gains in the clinical research process, marketing, and business operations. Dr Pratt has helped organizations large and small, providers and manufacturers/sponsors, to implement new processes and technology, redevelop clinical strategies, assess and retain talent, develop support materials and much more on a consulting basis since 2003. Multi-awarded at the divisional, country and global level by several Fortune 500 companies, Dr Pratt stays on the cutting edge through his activities as a member of the Applied Clinical Trials Editorial Advisory Board, as well as in-depth market research and analysis on an ongoing basis. Confidential. © CRUCIAL Clinical/Business Consultants. All rights reserved.
12.
OUR PRINCIPALS Mr James
Pedzinski A 26 year veteran of the Life Sciences industry, Mr Pedzinski has consistently ranked amongst the very best Sales Representatives in household name organizations such as Smith Kline Beecham, Boehringer Mannheim and Roche. Additionally he has spent considerable time developing in depth experience in eClinical technology solutions with established providers such as NextTrials, eTrials as well as small niche players. With experience running the gamut from CRO and Laboratory business planning through preclinical research planning and execution as well as business reorganization and alignment for successful venture capital funding clinical trial support organizations, Mr Pedzinski brings to the table a wealth of experience, and a broad range of working relationships with a highly diverse set of pharma, biotech, med device companies as well as support providers. Mr Pedzinski has been providing strategic selling services to the health industry on a consulting/contract basis since 2004, as is well known for his diligence, passion, and genuine concern for his customers. As the Head of Teva NeuroScience Outcomes Research commented recently “Jim...provided the highest level of customer service that one would expect...he was approachable, responsive and informative...I knew I could contact him..and he would find answer and, where necessary, a resolution to any problem” Confidential. © CRUCIAL Clinical/Business Consultants. All rights reserved.
13.
THE DECISION YOU
MAKE IS CRUCIAL TO YOUR SUCCESS… www.crucialcbc.com Confidential. © CRUCIAL Clinical/Business Consultants. All rights reserved.