Tim Denman

 Sharp Clinical Services, part of UDG Healthcare plc, (LON: UDG), the leading international provider of healthcare services, has expanded its storage and packaging facilities in the UK by an additional 5,000 square feet, creating an additional 10 roles at the site. The new facility based in Crickhowell is now the fourth unit of the existing Waller House building and comprises of 150 additional pallet spaces and two assembly lines. The Company’s investment is in response to new product introductions approved by the regulatory authorities. 

	Sharp Clinical Services is a leading provider of specialist clinical supply chain services to both large pharmaceutical and small biotech companies in the UK and US, from drug product development, analytical and manufacturing services through to increasingly complex clinical trial supplies packaging, clinical labeling and clinical distribution services. Sharp Clinical Services has a proven track record in managing the entire clinical supply chain and has a Global Depot Network of 18 depots supporting over 25 countries.

Ian Morgan, General Manager of Sharp Clinical Services UK, commented on the expansion:

 “The expansion of the Crickhowell facility is a landmark moment for Sharp Clinical Services in the UK, and enables us to deliver excellent, high quality service to our existing and new customers as demand for our services increases in the UK. The first commercial test ran at the end of May and full production will begin in July.”

Frank Lis, President of Sharp Clinical Services added:

 “This expansion has increased our global footprint and will allow us to provide our customers with a full range of services, from formulation development and pre-clinical supplies through to product launch.”

Articles

Sharp Clinical Services Expand Facilities In Crickhowell, UK

Parexel's President & COO Mark Goldberg sat down with 

 for a quick discussion on the trials market in Asia Pacific.  

When you look at trends for where the newest opportunities are for sponsors, our clients, to sell their drugs certainly Asia Pacific is the biggest growth area. There are other emerging regions, certainly, but if you had to pick one, Asia Pacific would be the one you would pick. Not as much India at the moment.  

Within Asia Pacific where do you see the most growth opportunities?

Lots of growth in Japan at the moment, driven by the fact that the government is really trying to address their historical drug lag. Approvals are happening sooner and there is more flexibility about the inclusion of data from other Asian populations. Japan is a little more relaxed now in terms of trial participants, not to the point that they would be willing to look at Western data but certainly from different Asian countries.  

The pharmaceutical market in China is certainly on the rise. Is there anything interesting going on there from the trial perspective? 

In China you have a lot of demand for clinical trials. You have a reshuffling of the regulatory authority, which is creating some delays in getting trials started. Right now it is taking between 12 and 24 months to get new trials started in China. It depends to what degree the indication is viewed as a priority by the Chinese government for their population.  

In the case of biologics, all phases of development, Phase I through Phase III, have to be done in China. This is relatively new requirement in the biologic space. For other indications that is not the case and you can include a sub-population in China within a larger global study. You have to agree with the Chinese authorities about how many patients from China would be required to meet their needs for local registration.  

Another aspect that makes conducting trials in China a little more difficult is the fact that to be an investigator you have to be certified by the government. There are still a relatively limited number of certified investigators. I think China is picking and choosing a little bit on what their priorities are.  

Parexel's President & COO Mark Goldberg sat down with Applied Clinical Trials for a quick discussion on the trials market in Asia Pacific.

Japan Relaxes Clinical Trial Regulations; China Still Strict

 as Vice President of Global Project Management. Gordon is responsible for the oversight of project management activities including quality deliverables, staff, project status, and budget oversight in more than 10 countries.  

 (Horsham, PA) announced the appointment of 

, PhD, as President of the DIA Board of Directors. Su is Senior Vice President and Head of Development Greater China Region of Beijing, Novartis Pharma Co., Ltd.  

 (Research Triangle Park, NC) announced the addition of 

, PhD, to its team. Mitchell adds to ClinPharm's areas of PK and clinical pharmacology, with regulatory affairs, medical writing, protocol development, and strategic planning services to help navigate client companies down the path to marketing approval.  

 (Staines, England) the European subsidiary of Tokyo-based Astellas Pharma, Inc., has appointed 

, PhD, as Senior Director, Market Access.  

, a global contract sales organization, from Celesio AG. 

, a Philadelphia-based benchmarking solutions and analytics company that helps life sciences organizations around the world plan for and negotiate the costs of clinical trials.  

 (Fort Lauderdale, FL) announced that its eClinical suite of applications has been licensed by 

. for two Phase III studies. Both of these 30-site, Phase III studies are evaluating the efficacy and safety of CTAP101 capsules to treat secondary hyperparathyroidism in subjects with stage 3 chronic kidney disease and vitamin D insufficiency. 

(Pittsburgh, PA) a global technology-driven provider of health outcomes services to biopharmaceutical organizations, medical device companies, and CROs, has been recognized by the Pittsburgh Technology Council in its 2012 Tech 50 Awards. ERT has been named a Life Sciences category finalist in the annual awards program, which honors high-growth companies in southwestern Pennsylvania's technology sector. 

 (St. Petersburg, FL) along with other healthcare partners, launched a quality improvement initiative with the goal of providing patients clearer medication information when they pick up prescriptions at the pharmacy. Catalina Health and other healthcare partners will disseminate newly-designed patient medication information (PMI) to patients filling prescriptions at participating pharmacies. 

 (Ivyland, PA) announced the launch of a new office and new business in Tokyo, Japan. Ashfield KK delivers outsourced contract services to the pharmaceutical and healthcare sectors. 

The National Institutes of Health/National Cancer Institute (NCI), 

(Reston, VA) has awarded a five-year research project grant to the Universities of Iowa, Pennsylvania, and Washington. The project aims to identify harmonized reconstruction parameters for each currently-produced positron emission tomography/computer tomography scanner for use in clinical trials. 

The Society of Nuclear Medicine and Molecular Imaging's

 (SNMMI) Clinical Trials Network will serve as an administrative coordinating body for the Image Reconstruction Harmonization Grant. 

(Amersham, UK) has expanded its document management facilities with the opening of a new records center in Chesham, Buckinghamshire, UK. 

Industry news focusing on the people and organizations who work in the clinical trials profession.

Business and News Update October 2012

(Research Triangle Park, NC) a pharmacovigilance services provider, has announced the addition of industry veteran 

 MBA, RAC, as Chief Compliance Officer. In his new role, Pierce will oversee DSA's Quality and Regulatory Compliance and Risk Management teams. Pierce has more than 35 years of government and industry experience in regulatory and quality compliance.  

 has joined the executive management team as Chief Commercial Officer. Engelhart will be responsible for leading business development, proposals and contracts, marketing, and sales activities worldwide. Prior to joining ACM Global, Engelhart was Chief Commercial Officer at Cryoport, Inc. a provider of leading-edge cold chain logistics services.  

 (Dublin, Ireland)has made two senior appointments in Early Phase and Epidemiology & Risk Management departments. 

MD, has joined ICON as Senior Clinical Research Physician at the Clinical Pharmacology Unit in Manchester, UK. Leung joins the company with over 23 years of hospital and pharmaceutical industry experience in a variety of medical specialties including diabetes, endocrinology, and general medicine. 

 has been appointed Director, Epidemiology and Risk Management Practice, ICON Late Phase & Outcomes Research. Anton has over 25 years of experience leading international epidemiologic, health economic, and outcomes research, and other market access initiatives.  

 (Cincinnati, OH), an end-to-end drug development service provider specializing in the 505(b)(2) process, has appointed 

 as Vice President of Drug Development. Barnette will be responsible for the growth of the company and excellent customer service utilizing his experience within the drug development industry and his knowledge of FDA regulations. He will be stationed in the Durham, NC office.  

 (Lyon, France) as Vice President, Clinical Operations for REGISTRAT-MAPI EU. Working as a key member of the organization's executive leadership, Doize will assume responsibilities for clinical operations in Europe and affiliated territories. She will be responsible for the strategic development and functioning of international operations to ensure that growth, profitability, quality, and customer service goals are achieved.  

 (Verona, Italy), an international full-service CRO has acquired 

an established international CRO with offices in the United States (Cambridge,MA) and the United Kingdom (Stirling, Scotland). Pleiad was launched in 1999, supporting clients in multiple therapy areas and with dedicated medical device and ophthalmology divisions. Additionally, Pleiad also possesses strong capabilities within statistics and data management.

(Wilmington, NC) has funded the strategic merger of

 creating an organization designed to accelerate clinical trial enrollment from beginning to end: Inclinix-PMG Holdings, Inc. The company will be led by 

 CFO. The company will operate in the short term as two divisions.

(Rockford, IL), a pharmaceutical, clinical, and commercial contract packager in the United States, and 

(Hey-On-Wye, UK), a leading supplier of pharmaceutical commercial packaging and clinical supply services in the United Kingdom, are further aligning their businesses to become a global end-to-end pharmaceutical packaging company. AndersonBrecon will feature 12 facilities across two continents, and more than 1,500 dedicated associates who will work to provide medications to patients in more than 100 countries around the world. 

 (King of Prussia, PA), a provider of payment technologies for the clinical trials industry, has been awarded the Philadelphia Alliance for Capital and Technologies Enterprise Award in the Technology Startup Division. Greenphire and other Enterprise Award winners and finalists were recognized at the 19th Annual Enterprise Awards gala in front of 1,200 prominent business leaders in May in Philadelphia. The Enterprise Awards honor exceptional technology and life sciences companies and entrepreneurs in the greater Philadelphia region each year.

(Horsham, PA), a provider of eSource solutions for clinical trials, was named to the Gartner's prestigious 2012 Cool Vendor List for life sciences. Gartner cited the potential to eliminate errors, cut costs, reduce timelines, and simplify clinical trial processes as reasons to include Clinical Ink this year. Clinical Ink is the only company on the list to focus exclusively on clinical operations. 

 (Princeton, NJ), inVentiv Health's clinical segment, and a leading provider of clinical development services to pharmaceutical, biotechnology, generic drug, and medical device companies has been named the recipient of the US Chinese Anti-Cancer Association (USCACA) Distinguished Partner Award for its support of oncology clinical trials and cancer research in China. USCACA is a non-profit organization that facilitates collaborations among cancer researchers and physicians in the United States and China. 

(New York, NY), a provider of eClinical technologies to the life sciences industry, announced that 

(Raleigh, NC), a therapeutically focused CRO, has selected Trial Interactive as its global electronic trial master file solution. Trial Interactive is a secure, web-based platform that reduces the redundancies inherent in paper-based TMF management. Trial Interactive's interface is available in more than 20 languages, which will enable INC Research to deploy the solution in the local language of the end user.

The Ethical Standards in Health and Life Sciences Group

 (London, UK)has published a new series of Clinical Trial Transparency Principles and Facts. This is the first time that leading healthcare professional bodies and senior representatives of the pharmaceutical industry have agreed to a joint approach on this issue. This is a step forward in the ongoing move across the entire research community to drive best practice in clinical research reporting.

 (New York, NY), an early phase and specialty CRO that provides clinical drug development services to the pharmaceutical industry, has opened a second Phase I unit in Southern New Jersey. The 50-bed capacity, 15,000 square foot specialty pharma Phase I unit features semi-private rooms, a large PK sampling facility, a bioanalytic laboratory, pharmacy, and exam rooms.

CTI Clinical Trial and Consulting Services

 (Cincinnati, OH) has announced the formation of a new, wholly-owned French subsidiary, CTI Clinical Trial and Consulting Services SARL, and the opening of an office in Paris, France. The new location continues the company's expansion throughout Western Europe. CTI has been working for more than a decade in the drug development industry in North America, Europe, and South America, specializing in clinical research programs involving critically ill patient populations. 

 (Raleigh, NC), a leading clinical research organization, announced the expansion of operations in the Netherlands and the United Kingdom to accommodate staff growth and strong client demand for Phase IIa-IIIb service offerings. Located in the thriving city of Utrecht, NL, the new Dutch facility will host 20-plus employees and is the first PRA office in that region to primarily support product registration trials.

 (Riom, France), a CRO that provides fine chemistry services, has moved into new premises in Riom, near Clermont-Ferrand, in the Auvergne region. The move will strengthen Roowin's position as one of the few companies in France that offers a comprehensive range of services, from early-stage research to the production of GMP batches for Phase I and II clinical trials.

(Evanston, IL), a digital services provider to the global biopharma industry, has released a new generation of eClinical technologies for mobile devices. The new mobile-friendly platforms deployed by MedPoint include: TriPort Clinical Trial Portal, a secure, fully validated technology that delivers study-specific information, training, and communications; TelePoint Virtual Meeting System, which simultaneously connects participants from desktop computers, smartphones, and tablets; ActivMedia Modules, which engages users for self-learning, real-world simulations, and training certification; SFX Site Feasibility Xelerator, can complete survey forms over mobile devices.

In the July news section, the article "Managing Budgets in Complex Times with Tight Variances" was published with inaccuracies. Please visit 

www.appliedclinicaltrialsonline.com/budgets

Business and News Update August 2012

(King of Prussia, PA), a full-service contract research organization that provides core clinical research and development services, has named 

 Senior Vice President of Global Clinical Development. 

has been introduced as Executive Director of Corporate Development. 

 has joined the organization as Executive Director of Quality and Regulatory Affairs. O'Brien will be responsible for all quality assurance and regulatory affairs operations, including ensuring regulatory compliance and computer system validation processes. 

(ACR) (Reston, VA) has named medical imaging contract-research veteran 

 MD, Chief Medical Officer of ACR Image Metrix™.  Image Metrix is an imaging contract CRO and for-profit subsidiary of the ACR. Perlman has more than two decades of experience in radiology. 

 PhD, has joined the Infectious Diseases leadership team of INC Research, LLC (Raleigh, NC) as Vice President, Infectious Diseases. Young will lead the company's infectious diseases therapeutic unit globally. 

 (Princeton, NJ) announced the addition of two industry veterans to the company's leadership team. 

 joined Idis as Global Director of Regulatory and Medical Strategy, while 

 was appointed Senior Vice President of Global Business Development. 

 (Chippenham, UK), which specializes in developing therapies, principally for the treatment of respiratory diseases, announced that 

 BSc, PhD, MBA, has joined the company's board. 

 has joined the executive management team as Head of Business Development in Europe. Struik brings vast experience in the clinical research arena having worked in the clinical trials industry for more than 13 years and in all major therapeutic areas. 

 has joined as a biostatistician. Yeh brings with her over 20 years of experience working for Procter & Gamble (P&G). During her time at P&G, she served as both project statistician and statistical function leader for many different areas, such as gastroenterology, cardiology, pet care nutrition, and health technology. 

(King of Prussia, PA), a leading global provider of Microsoft SharePoint-based compliance solutions to life sciences organizations, to deliver solutions that provide easier access to clinical trial information and decrease the timeline for FDA submissions. 

 (New York, NY) worked with R&D and technical services institute

to upgrade the technology it uses to provide statistical and data coordinating services for National Institutes of Health-funded research. 

 (San Francisco, CA) have collaborated to co-promote clinical and commercial solutions for biopharmaceutical companies to reduce the time and expense associated with developing and marketing novel therapies. Quintiles will incorporate Archimedes' ARCHeS Innovator, and modeling consulting solutions, into its existing offerings. ARCHeS Innovator enables users to run clinically realistic virtual trials on any population and create compelling evidence.   

(Chicago, IL), a leading provider of cloud-based clinical trial operations and analytics products that help make the planning, sourcing, and tracking of clinical projects and financial performance faster and more accurate. The combination of the two companies is expected to deliver a comprehensive closed-loop clinical trial management offering from planning to payment. 

(Raleigh, NC), a therapeutically focused CRO has entered into a functional service provider alliance with 

 (Northbrook, IL), to drive global consistency, save time, and reduce costs for multiple clinical development programs across several therapeutic areas. In an initial three-year agreement, INC Research will deliver key functional services, including clinical monitoring, clinical data management, trial master file management, site start-up, and study feasibility activities.  

 (Exton, PA), a global CRO, will develop clinical trial supplies with 

 a biotech company focused on the research and development of compounds to regress atherosclerotic plaque. Under the agreement, Frontage will commence work on the formulation, compounding, and tabletization of the company's AHRO-001 product in advance of the upcoming Phase I human clinical studies. AHRO-001 is AtheroNova's first novel application for the treatment and prevention of atherosclerosis. 

 (Princeton, NJ), a provider of drug development services, and 

 a leading Japanese laboratory testing company, announced the expansion of the Covance-BML clinical trial laboratory in Kawagoe City, Saitama Prefecture, Japan to enhance the capacity and capabilities in the region. The companies, which opened the lab together in 2010 as part of a five-year agreement, will launch several new expansion-related services.  

 (Raleigh, NC), a CRO, announced a new agreement with 

 for a series of Phase III studies to develop several biosimilar drugs on a worldwide basis. PRA will serve as the sole provider of CRO services for these studies. The agreement is intended to govern the entire anticipated scope of Amgen's global biosimilar portfolio. 

 (Manchester, UK) has strengthened its leadership position in Poland with the acquisition of 

. Based in Warsaw, Medical Centre Osteomed is an FDA audited clinical research company, whose client list includes many of the world's leading pharmaceutical companies and CROs. 

(Bangalore, India) an NSF International Health Sciences Company with more than 25 years of experience in the pharmaceutical industry, has signed a collaborative agreement with 

of Bangalore to expand pharmaceutical training, auditing, consulting, and testing services throughout India. 

(Madison, WI) has launched the newest member of the Allegro®  product line: Allegro CTMS@Network™ . The new product aims to improve site selection, study start-up project management, and visibility into study conduct across multiple sites. 

The Clinical Data Interchange Standards Consortium 

(CDISC) (Round Rock, TX) has released the first iteration of a protocol representation "toolkit" for clinical research. The kit is designed to make it easy for authors of a research plan or protocol to reap the benefits of the protocol representation model, which has been developed over the past decade by global clinical research experts from academia, industry, and government. 

Clinical Data Interchange Standards Consortium 

(Round Rock, TX) won two recent Global R&D is Innovation Awards at Genzyme/Sanofi. GetSMART, which involved implementation of a number of CDISC standards, won in the Internal Business Value category. RegistryNXT!, which is based on the collaborative BRIDG model, won in the Value to Patients category.  

(Tempe, AZ), a community-based network of clinical trial sites, has been named Best Clinical Trial Site Network by the World Vaccine Congress. The award was announced at the 2012 Vaccine Industry Excellence Awards in Washington, DC. The VIE Awards celebrate the leaders, innovators, and pioneers in the vaccine industry. Clinical Research Advantage also received second place for Best Clinical Trial Site. 

(Middlesex, UK) has completed all the commissioning work for its new operational hub in Feltham, UK. The new location is within four miles of Heathrow Airport and part of the North Feltham Trading Estate Industrial Centre. 

 (Seattle, WA), a provider of global central laboratory services for the biopharmaceutical industry, has released its proprietary clinical trial sample tracking and management service: SampleGISTICS™ . The system provides web-based, real-time sample tracking including collection, shipment, and receipt at any laboratory or location worldwide. 

 (Redwood Shores, CA) has released the newest version of its Health Sciences Clinical Development Analytics. The application includes new functionality that expands visibility into clinical programs and studies, improves the quality and timeliness of clinical trial data, and helps to simplify and prioritize the rapidly expanding responsibilities of study managers, clinical data managers, and site monitors. 

• In response to regulators' increasing emphasis on patient centered data, including patient-, clinician-, and observer-reported outcomes (PRO, ClinRO, and ObsRO), 

 (Pittsburgh, PA) is integrating its consulting division—formerly PRO Consulting™ —into its portfolio of clinical outcome assessment consulting services. The new service will be called invivodata Consulting and will complement and integrate with the company's eSolutions and regulatory services. 

 (San Francisco, CA), an innovative clinical technology and services company for medical and pharmaceutical research, debuted its iPad application explaining informed consent prior to clinical trial patient enrollment. Using animation and other visual imagery, the application condenses the complex and critical disclosure information required at the start of a clinical trial into an easy-to-understand, digitized format.   

 (London, UK), a global CRO, announced the establishment of a new legal entity in Taiwan. Umakanta Sahoo, Chiltern Executive Director, Asia Pacific and Managing Director, India, will be leading the effort in Taiwan. 

 (Rochester, NY) has advanced its hybrid central lab model in Mumbai, India with a state-of-the art operational facility dedicated to managing clinical trials testing in India and provides study support throughout Asia Pacific. ACM Global oversees the full complement of study support to keep clinical trials on schedule and on budget, including kit building, shipping logistics, project management, data management, and site support. 

 (Tampa, FL) has gone live with its next-generation health and research informatics platform, built on Oracle Health Sciences solutions. In early deployment, the new platform enables Moffitt to accelerate clinical trial patient recruitment and advance personalized medicine. The new informatics environment supports Moffitt's Total Cancer Care™  program by generating new intelligence from existing systems. 

(Cary, NC) announced the availability of a new report titled The State of Patient Recruitment in Clinical Trials, which provides sponsors and service providers with valuable insight into the activities and strategies that drive and restrict patient recruitment in clinical trials. 

 (Fremont, CA) announces its Research Accelerator platform for the life sciences, an end-to-end management solution for R&D that integrates clinical information management technology and business outcomes-based methodology for informed decision-making in R&D.  

 (Redwood Shores, CA) announced the latest version of its Translational Research Center, a platform that enables secondary use of electronic health records, administrative data, and omics data to help accelerate biomarker identification for drug discovery, clinical development, and translational research. This new release integrates genomic visualization tools that provide holistic views of multiple omics data modalities to enable systems biology-based approaches essential for understanding disease. 

, designed to give clinical trial sponsors and sites clinical training capabilities for site operations.The web-based application tracks, validates, and reports investigator training activity through one interface. 

(Charlottesville, VA) introduced OpenQ SafeGuard™ , a social enterprise compliance suite for managing social compliance risk. This patent-pending technology collects activity feeds, posts, and documents from social platforms and other enterprise interactions, to proactively identify and classify business and compliance risk. An intuitive interface helps manage compliance cases with classification of risk level according to industry driven and company-defined priorities. 

 (Malvern, PA) has expanded its suite of eClinical software solutions with Prime Publisher™ , a concatenation tool designed to streamline the content review process and combines multiple data forms into a single, navigable format. Prime Publisher simplifies processes such as reviewing large sections of the eCTD by combining them in a single document. 

 (Chicago, IL) released Merge eClinical OS, a new clinical trial operating solution that provides end-to-end study support for trials of all sizes. As a single, web-based solution, it has the flexibility to support trials in any phase, and capture any type of data, from any source, over any modality. Merge eClinical OS also has the scalability to grow if a trial increases in size, number or complexity. Merge eClinical OS provides a complete menu of clinical trial capabilities that can be mixed and matched to build a solid foundation for each trial environment. 

Business and News Update July 2012

As anyone who has started a new job can tell you, those first few days, weeks, or even months can seem like a never ending sea of confusion without a shoreline in sight. One increasingly popular way to help ease the transition into a new role in any industry and especially in the clinical trial space is through a mentoring program. 

A successful mentoring program will pair an industry veteran with a company newcomer to help the rookie familiarize him or herself with the company's culture and hopefully build a loyal bond with the organization. Mentoring programs will vary from industry to industry, but one of the tenets of a quality program is the ability to lower turnover and keep the employee happy and productive. 

"I think in the clinical trial industry mentoring can really help new employees learn about the partnership between the site that is conducting the research and the sponsor," Deborah Lasher, Clinical Research Specialist at Medtronic said. "That is something you don't learn in school or from a book necessarily. 

"The ability to speak to a mentor after a meeting or a site initiation and ask, 'How did I do? How did I come across? Did they understand the training?' That kind of feedback is invaluable." 

Mentoring is a two-way street, and often the mentor receives just as much from the pairing as the mentored—beyond the positive feeling that comes from helping a younger colleague gain some valuable industry insight. For example, the younger employee often has a stronger grasp of technology and is able to pass that knowledge onto the mentor in an even exchange of ideas. This two-way street is referred to as reverse mentoring.  

The mentoring program at Medtronic has been wildly popular and successful. "On occasion the company has to turn people away simply because they don't have enough mentors," Lasher said. "People realize that it is really an effective way to learn quickly and take advantage of the experience of others and vice versa." 

One increasingly popular way to help ease the transition into a new role in the clinical trial space is through a mentoring program.