DIA Conference Recap: Come join our discussion!

Advanced Clinical attended the DIA conference June 13-17^th, 2010 in downtown DC at the Washington Convention Center. It was an awesome week. We were able to meet so many people, while networking, brainstorming, and discussing numerous topics surrounding the clinical and pharmaceutical industry.

Our team was able to sit in on and discuss many interesting presentations. The one presentation that really hit it for us was the session “Fiscally Responsible Protocol Development: Minimizing Potholes and Avoiding Sinkholes” hosted by Anna Hindle, Anne Cropp and Ken Getz. The session outlined:

a) The financial impact of protocol amendments including the hidden costs

b) Protocol amendments correlation with therapeutic areas and functional areas, e.g., data management, clinical operations, etc.

c) Triggers/causes of protocol amendments

d) Characteristics of protocols that generate lots of amendments, e.g., the more Investigator sites, the more amendments

e) Amendments that are avoidable and amendments that are not avoidable

f) Lessons learned and tips / techniques for circumventing / preventing the avoidable amendments

Some interesting facts about amendments we learned: 40% of amendments occur before the first patient is in, 631 hours/amendment approval, 484 hours/amendment to implement, and a minimum of $60K per amendment - $400K per amendment. We also learned that the key triggers of amendments were due to: standard of care changes, safety issues, and the need to deal with sub-populations.

Advanced Clinical had some additional thoughts on the amendment front upon reflecting on this presentation:

a) Would be good to determine the characteristics of a good amendment and a “bad amendment”

b) It’s important to perform the analysis of doing the amendment vs. not doing the amendment

c) Perhaps consider the following items to deal with amendments more efficiently:

• Think about doing amendments in “release” schedules like people do in software development
• Use tools that allow standard language document components – there are some good document management tools that have this functionality
• Create guidelines for the organization to evaluate whether or not an amendment should be performed
• Understand the causes of amendments in your organization. Gather data around amendments for therapeutic area; cause; sub-population; hours to design/gain approval for amendment; hours to implement amendment
• Create an ecosystem of experts to review the protocol before finalizing it to avoid amendments. Put more time into the protocol up front to ensure completeness and consideration of key areas where changes could occur
• Make the language more flexible in the protocol to avoid the amendment, e.g., put in “5-9 sites” instead of “7 sites”

On top of the presentations, the exhibitions were excellent. Our favorite was Oracle’s demonstration of their new Oracle Clinical product. We were able to talk with Oracle and their product roadmap as it relates to their EDC product, “RDC”. Also we were able to discuss Oracle Clinical’s “big picture architecture including IVRS, IWRS, EDC, Business intelligence as well as the anchor Oracle Clinical Product.

Were there any presentations or exhibitions you particularly enjoyed or thought was informational? What are some of your thoughts on the presentations given? Hanging questions? Comments? Please let us know! Come join our discussion and comment or write on our wall in our Blog or on our Facebook page. We’d love to hear your ideas and takeaways from the DIA Conference.

AC also had the opportunity to host OYA for a networking happy hour. It was a huge success! We were able to gather so many great people from the DIA Conference. There was a lot of relaxing, socializing and brainstorming for advancing discoveries. If you weren’t able to make it, please join our discussion for Advancing Discoveries on our Facebook page at www.facebook.com/AdvClinical

See www.advancedclinical.com

Men’s Health and Cancer Awareness Week

With Father's Day coming up this Sunday, June 20, it also marks the week for men's health and cancer awareness. See our blog post on women's cancer awareness week.

Due to a lack of awareness, poor health education and culturally induced behavioral patterns in their work and personal lives, men’s health and well being are deteriorating rapidly. Statistics show that men live sicker and die younger than American women. Men’s Health Week is to bring awareness to the fact that men can do things to prevent suffering and even dying from many avoidable and treatable diseases. It is important for men to pay attention to their bodies and visit a doctor whenever suspicious symptoms arise. Annual physicals are recommended to ensure proper screenings are done. Early detection and treatment of disease is extremely important to maximize your health. To download a Blueprint For Men’s Heath – a publication that discusses the main health issues that men face today – click on this link here.

Best wishes to all Fathers this coming Sunday. To quote Congressman Bill Richardson (Congressional Record, H3905-H39906, May 24, 1994):

“Recognizing and preventing men’s health problems is not just a man’s issue. Because of its impact on wives, mothers, daughters, and sisters, men’s health is truly a family issue.”

Medicine is making new strides everyday to advance discoveries to ease symptoms, cure disease, and better the human situation. Clinicians are a part of this discovery process, so it's important that your needs as an employee are met, too. 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

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

Contest Extended Through July

NOW--Extended through July:

"What's Your Dream Job?"

Common complaints of clinical job positions from GlassDoor.com are: “Lack of personal development opportunities," "lack of career progression within the company," "a lot of talk and no action," "under pay from market rate," and "no incentive to do better.” In addition, several former clinical employees working with CROs and clinical contract staffing have stated on Jobvent.com that they are "fed up with back-stabbing and incompetence,” an “unhealthy environment,” and high turnover.

World-class Clinical Strategic Sourcing Organization (hybrid CRO and Clinical Contracting solutions), Advanced Clinical, wants you to “Design your dream job,” and give us suggestions on how to provide the perfect work environment for clinical consultants. We will not only take requests to heart, but match you with a job as best as we can.

The best entry will win a $200 gift card to any store of his or her choosing, and two runners-up will each win an iPod shuffle.

You can enter with a description of your dream job, a video, or any other creative form.

Design your dream job here.

What's your dream job?

For winners announcement, you can follow Advanced Clinical on facebook or on one of our social networks:

• http://www.facebook.com/pages/Advanced-Clinical-Jobs/312691418900?v=wall&ref=ts
• http://twitter.com/AdvClinicalJobs
• http://youtube.com/AdvancedClinicalJobs
• http://advancedclinicaljobs.blogspot.com/
• http://advancedclinicaljobs.wordpress.com/

See www.advancedclinical.com

Job Opening -- VP Advanced Clinical

Job Title: Vice-President
Reports To: Chief Executive Officer
FLSA Status: Exempt
Prepared By: Kimberly Marzano (email)
Prepared Date: 5/12/2010

SUMMARY

The Vice President will serve as head of the local biometrics contract research organization (“CRO”), with the ultimate responsibility of achieving established strategic, operational, and financial objectives, both short-term and long-term. The VP will be involved in all aspects of the business, including strategic planning; resource planning, management, and utilization; operations and quality management; business development; and budgeting and financial planning. The VP will have 4 to 6 direct reports who will comprise the management team. The team, particularly vis a vis the leadership skill of the VP, will be expected to foster a unique culture and work environment that will consistently drive both outstanding business performance and exceptional employee satisfaction.

PRIMARY AREAS OF RESPONSIBILITY include the following:

* Thoroughly understand and embody the vision, mission, and values of the company.
* Establish a professional leadership presence with all internal and external constituencies, which instills respect, confidence, and trust.
* Coordinate assignments of resources and projects across teams and ensure all teams stay on target.
* Develop and maintain competency framework, training programs, and attract and retain employees to foster best in class clinical operations.
* Through leadership style, develop a positive and enthusiastic culture with optimal communications.
* Promote a work environment where staff operates with a high sense of accountability, thereby allowing individual, team, and company goals to consistently be met.
* Identify business improvement opportunities and participate and/or lead in creating solutions which improve the client’s efficiency and effectiveness.
* Ensure that all client SOPs are adhered to and federal regulations are followed with respect to each client.
* Ensure that all vendor contracts appropriately delineate the responsibilities of the various parties involved in the clinical study.
* Conduct services meetings with current clients to gather feedback and maintain relationships.
* Work closely with the CEO and CFO on financial matters, including contract negotiations, budgeting, forecasting, and accounts receivable excellence.
* Work closely with the CEO, CFO, and the management team on executing the business strategy, to maximize revenue and profit growth and, ultimately, shareholder value.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

* 5-7 years of relevant experience in a CRO, managing other staff members
* 15 years in CRO environment
* Masters or PhD preferred
* Strong written, oral communication and presentation skills with excellent interpersonal skills
* Good Clinical Practices (GxP Regulations; ICH guidelines; Good Quality Practices)
* Excellent problem solving skills in highly complex situations
* Exceptional time management skills. Able to balance many competing priorities with grace.
* Good negotiating skills
* Excellent judgment and decision making skills
* Leadership and line management skills with a balanced management approach which promotes collaboration and teamwork
* Management style that empowers employees
* Intellectually, emotionally, and logically smart. Well-grounded with solid common sense and direct approach that effectively deals with a broad range of people, backgrounds, and skill levels.
* Ability to establish and maintain effective working relationships with co-workers, managers and clients
* Team player and proven team builder. Good facilitator and collaborator. Persuasive. Can focus and continuously reinforce managements’ efforts to meet their goals.
* Ability to identify business improvement opportunities and to then effectively implement and institutionalize those improvements
* Able to analyze business intelligence and reports and to synthesize such information into action.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

See www.advancedclinical.com