Showing posts with label clinical. Show all posts
Showing posts with label clinical. Show all posts

Thursday, March 3, 2011

New 2011 Webinar Series to Educate, Enhance and Empower Life Sciences Professionals

We have just launched our 2011 webinar series to educate, enhance and empower life sciences professionals. Webinar topics range from how to position for optimal capital raising, successfully commercializing products, picking the right growth targets, optimizing clinical trials, heightening R&D productivity, advancing in a shifting job market, creating a workforce strategy, and more.


Each of the webinars addresses how to respond to different critical issues in life sciences to become more efficient and effective. Attendees will range from clinical research professionals to broad leadership executives.


The first of the 13 webinars in the series, titled “Dynamics in the Life Science Industry: The Tsunami in Full Swing,” begins on March 10. This webinar will examine the state of the industry, the implications for changes as well as methodologies and leading practices to improvement.


“Many in life sciences understand the challenges that continue to plague our industry, as well as those that lie ahead,” said Advanced Clinical Executive Vice President Rosemarie Truman, a 19-year strategy veteran and chief presenter of the series. “From the economic crisis, globalization, new business models, the transition to personalized medicine and Health Care Reform, life sciences professionals have experienced massive disturbances, further strained by numerous quick fixes. This series will offer information and solutions to show life sciences professionals how to effectively respond to these challenges to achieve sustainability.”


Online registration is now open. Webinars are offered to participants at no cost, with the exception of one for which contact hours may be earned. Interested attendees can register online at advancedclinical.com/webinars.

Thursday, September 30, 2010

Advanced Clinical Announces Bernice Welles as a Core Member of its Strategic Advisory Ecosystem

Advanced Clinical, a leading provider of clinical research services, announces Bernice Welles as a core member of its strategic advisory ecosystem.

Bannockburn, Ill. (Vocus) September 30, 2010

Advanced Clinical, a leading provider of clinical research services, announces Bernice Welles as a core member of its strategic advisory ecosystem.

As a strategic advisor, Bernice Welles has contributed to Advanced Clinical’s Industry Leading R&D Performance (ILRDP) framework that seeks to make the “business of R&D” more effective and efficient for Life Sciences companies. Bernice has been a key driver in the development and regulatory approval of drugs, biologics, devices as well as combination therapies across multiple therapeutic areas. “Moving a drug and/or biologic from development to approval is, possibly, the hardest earned process in the Life Sciences industry,” says Bernice Welles, Advanced Clinical Strategic Advisor.

Welles’ accomplishments span several leadership roles in companies at different stages of growth. At Genentech, Welles was appointed to several management positions to drive the drug and biologics development portfolio across multiple therapeutic areas. Two of Welles positions included: Senior Director of the Specialty Therapeutics Unit and Vice President of Product Development. One important program that Welles progressed was the Lucentis injection for wet age-related macular degeneration (AMD). AMD is a disease of the eye that is the leading cause of blindness in older Americans and causes loss of the ability to see straight ahead and may make it more difficult to read, drive, or perform other daily activities. By moving forward this program, several thousand patients were able to be treated.

Welles held a Venture Partner position at MPM Capital LLP, where she participated in discussions on medical devices and helped assess device instruments. At MPM, Welles also took the lead on several investments and helped portfolio companies such as CoTherix maneuver the regulatory process leading to an early approval for Ventavis®, a new therapy for pulmonary hypertension.

Welles currently holds executive positions as CEO of Alquest Therapeutics Inc. and Vice President, Clinical and Regulatory, of Enject Inc., both innovative biotechnology startup companies.

With years of experience heading teams across functional areas, Welles credits integration as being one of the keys to her success. Using her capability to integrate the knowledge she has gained during her career, Welles is able to pull together all of the elements of clinical and regulatory as well as leverage the science behind development programs to create a significant, positive impact on the Life Sciences industry.

“I am proud to be working with Advanced Clinical,” said Bernice Welles. “Being part of this expert strategic advisory team allows me to continue to work with a topflight team to create new levels of R&D Productivity for companies in Life Sciences and bring much needed treatments to the market for those who need them.”

About Advanced Clinical: Advanced Clinical provides consulting services, strategic sourcing (CRO), talent management, and technology solutions to the Life Sciences industry. With 15+ years of experience, Advanced Clinical is an established presence in the clinical research field, providing services specifically for Pharmaceutical, Biopharmaceutical, Biotechnology and Medical Device organizations. Advanced utilizes a value-based, “One Team” approach. To learn more, visit http://www.advancedclinical.com/.

Contact:
Rosemarie Truman
rtruman@advancedclinical.com
1200 Lakeside Drive
Bannockburn, IL 60015
Ph: 202-438-2208

Thursday, June 10, 2010

Advanced Clinical: The CRO with Experienced Employees

Advanced Clinical has advanced many discoveries and has experience in over 192 trials in many therapeutic areas across Phases 1 though 4. Over the years, we've worked together with pharmaceutical companies to enhance medicine in disciplines which include but are not limited to:

1. Analgesia
2. Anti-Infective
3. Antiviral
4. Cardiology
5. Endocrinology
6. Gastrointestinal*
7. Geriatrics
8. Gynecology*
9. Hematology
10. Infectious Disease
11. Infertility
12. Musculoskeletal
13. Neurology
14. Oncology
15. Urology
16. Ophthalmology
17. Renal
18. Respiratory
19. Rheumatology*
20. Women's Health

*Advanced Clinical has over 25 trials' experience in these indicated disciplines.

Of our 192 trials, a whopping 191 of them used Advanced Clinical's Data Management service. Our Data Management service is reliable, resilient, and depended on by the best pharmaceutical, biotech and medical device companies in the industry. Our technology platform utilizes state-of-the-art tools: Oracle Clinical, Electronic Data Capture (EDC), and IVRS and IWRS (Interactive Voice or Web Response Systems).

Advanced Clinical also adheres to CDISC and SDTM standards with integrity checks and trial monitoring reports. Advanced Clinical is compliant with ICH, the FDA (21 CFR part 11) and GCP.

Our Biostatistics team is among the best in the nation and we continue to add strength and capabilities to the team in strategic therapeutic areas.

Advanced Clinical is prepared to handle any size trial. Within our body of work, 15 percent had over 500 subjects; one of those trials had over 5,000. We've done trials within the US at one site, and globally over hundreds of sites. Whatever your trial needs are, we will develop a plan and do our part to partner in your development.


Advanced Clinical's leading practices help drive the speed, improve the quality, and ensure the highest probability of success at the lowest total cost of ownership. Some of the delivery assets we use are:

• Our approach to collaborate, innovate, and optimize. Advanced Clinical believes in working together in collaboration, innovation through the Industry Leading R&D Process, and maintaining a continuous learning approach to optimize trials.

• Resource Management Model. Advanced Clinical not only retains, but nurtures our consultants to keep the best ones loyal and available for our exciting projects.

• Team Integration. Advanced Clinical wants to make the client team and the Advanced Clinical team integrated into one.

• Risk Management. Advanced Clinical identifies, assesses, prioritizes, mitigates, and tracks risks to proactively avoid issues that might arise

• Continuous Learning. Continually improving the trial as it goes on will optimize its overall success.

• Ramping. Advanced Clinical onboards, trains, and adapts the team to the client's environment, culture, project and needs.

• Project Management with Supply / Demand Management. Advanced Clinical will ensure clients get the right team, at the right time, and with optimal productivity with collaborative project management.

Use a clinical research organization with experience and an approach to support your growth: Advanced Clinical.

Our employees are well-versed in all of the above areas, and we take great care of them. If you want to have a more fulfilling job, check out our design your dream job contest: you may win a $200 gift certificate and also get your dream job!

See www.advancedclinical.com

Friday, May 21, 2010

Big Pharma aims for reinvention

With some of his most profitable medicines going off patent, and the uncertainty of replacement drugs continuing to rise, US healthcare reform has been the least of Andrew Witty’s recent worries.

When the chief executive of GlaxoSmith­Kline presented his company’s most recent financial results last month, he gave a sense of how the UK’s biggest drugmaker – and the industry more generally – is responding to structural pressures: diversify to survive.

For his company, he says, this means a shift away from “white pills in western markets”, with the proportion of traditionally core patent-protected, chemically based drugs, which are sold mainly in North America and western Europe, falling to just more than a quarter of total sales.

For many years, large companies such as GSK have relied on a handful of typically high-priced, mass-market “blockbusters” that generate billions of dollars a year in sales. But as patents expire on drugs such as Lipitor, Pfizer’s anti-cholesterol medicine that is the biggest selling medication in history, big pharma is having to rethink its business model.

Most large pharmaceutical companies have adopted four principal strategies to diversify. First, expand the range of products in the research and development pipeline and the use of external as well as in-house scientists to discover them. Second, expand geographically, especially into emerging markets. Third, increase sales of products other than patented prescription medicines. Fourth, experiment with greater flexibility in pricing in different countries and with ways to ensure drugs provide value for money.

Read the rest of the article -- FinancialTimes.com

Visit us at www.advancedclinical.com

Wednesday, May 12, 2010

Ramping and Onboarding with Advanced Clinical

Advanced Clinical's approach to onboarding, training, and adapting team to the client environment is a crucial key to trial acceleration. One week leading up to a trial, Advanced Clinical identifies potential team players, assessing their fit culturally and their competencies. The week of the trial, you interview the team members to gauge comfort level, then the employees engage in Advanced Clinical on-boarding / training, as well as your specific training. Many times, we try to prepare candidates for your trial in advance; therefore, we pre-screen candidates with you, and get them onboarded and trained, so that when you need them, they’re ready for you!

Also included in the rampup process are team “integration” sessions to clarify the plan/schedule, deliverables, roles, project handoffs as well as communication. AC also has team building activities to ensure that the teams will work harmoniously together and the team builds strong chemistry to ensure close collaboration.




Advanced Clinical wants to make sure all steps are taken to provide a “dream team” ready to work efficiently and effectively.

Advanced Clinical strives to make the best environment for our employees. We hope you like our ramping program. Enter our “Design Your Dream Job” contest and you could win a $200 gift card to the store of your choice, an iPod shuffle, and even your dream job!

See www.advancedclinical.com

Thursday, April 15, 2010

Stay in the loop with Advanced Clinical's Team Integration

Several studies* have been performed on the linkage among team building, team cohesion, and team performance. An integrated team will achieve improvements in performance by developing the right "Team Culture" and adopting the behaviors needed to support and reinforce that culture. A strong Team Culture leads to reduction of waste, duplication, unnecessary processes and procedures. Most importantly, it leads to the willingness to succeed.

Many times there is limited or no effort taken to create a joint view of the goals that should be achieved, build trust among team members, and to integrate the team. As a result, the team is not productive as a unit as they become "disengaged". Disengaged employees are 33% less productive on average according several reports*. This costs companies a lot of money, risk, and time.

To keep clinicians and consultants in the loop, Advanced Clinical has built our "Team Integration Method". Our method succeeds in creating a completely harmonized team, whether working on-site or off-site to ensure maximum employee engagement, productivity and overall performance.

Advanced Clinical believes our consultants should be "close" with not only their colleagues on a project, but the project managers and the client's team as well. Bonding exercises and introductions take place before our clinical trials. Mutual respect and complete communication is ongoing to keep workplace karma good, and, ultimately, to ensure successful trials completion.

We've launched our “Design Your Dream Job” contest to identify the best ways to make employees happy and productive in the workplace. You could win a $200 gift card to any store of your choosing, an iPod shuffle, and maybe the job of your dreams.

Enter today.

*Sources:
Bloom, G. A., Stevens, D. E., and Wickwire, T. L. (2003). Expert coaches’ perceptions of team building. Journal of Applied Sport Psychology. 15: 129-143.
Crron, A.V., Brawley, L.R., and Widmeyer, W. N. (1985). The Group Environment Questionnaire.
Carron, A.V., Bray, S.R., and Eys, M.A. (2002).Team cohesion and team success in sport. Journal of Sports Sciences, 20, 119-126.
Dirks, K.T. (2000). Trust in leadership and team performance: evidence from NCAA basketball. Journal of Applied Psychology, 85(6) 1004-1012.
Ebbeck, V. and Gibbons, S. L. (1998). The effect of a team building program on the self-conceptions of grade 6 and 7 physical education students. Journal of Sport and Exercise Psychology, 20; 300-310.
Everett, J. J., Smith, R. E., and Williams, K.D. (1992). Effects of team cohesion and identifiably on social loafing in relay swimming performance. International Journal of Sport Psychology. 23: 311-324.
Kozub, S.A. & Button, C.J. (2000). The influence of a competitive outcome on perceptions of cohesion in rugby and swimming teams. International Journal of Sport Psychology. 31: 82-95.
Landers, D. M. and Luschen, G. (1974). Team performance outcomes and the cohesiveness of competitive coacting groups. International Review of Sports Sociology. 5: 57-69.
Martin, R. and Davids, K. (1995). The effects of group development techniques on a professional athletic team. The Journal of Social Psychology, 135 (4) 533-535.
Meyer, B.B., Wenger, M.S. (1998). Athletes and adventure education: An Empirical Investigation. International Journal of Sport Psychology, 29, 243-266.
Murphy, J. M. (2001). The effect of a one-time team building exercise on team cohesion.
Sencecal, J., Loughead, T.M., and Bloom (2008). A season-long team-building intervention: examining the effect of team goal setting on cohesion. Journal of Sport & Exercise Psychology, 30, 186-199.


See www.advancedclinical.com