Miraj Barodia

The Association of Clinical Research Professionals (ACRP)

 Board of Trustees announced the appointment of 

 as Executive Director of ACRP. Kremidas brings to ACRP more than 30 years of experience in the health care industry, including positions in the lab, sales, marketing, strategic sourcing, and clinical operations at Eli Lilly and Company, Quintiles, inVentiv Health, and most recently CenterWatch.

 a provider of clinical research quality performance indicators, announced that 

 has joined the company as its new Chief Commercial Officer (CCO). He will lead CRO Analytics overall commercial strategy and execution, and will spearhead the launch of the company’s flagship product, Performer

, through the implementation of marketing, sales, and commercial operations and infrastructure.

 as Vice Chairman, Deloitte LLP, and leader of its national life sciences sector practice. The practice is one of the nation's largest accounting and consultancies covering life sciences with more than 4,000 professionals serving major pharmaceutical, medical device, biotechnology and consumer health care manufacturers. A principal with Deloitte Consulting LLP, Reh brings to the role significant experiences in both client service and practice management. 

 a biosimulation technology-enabled drug development company, announced that 

, has joined its Simcyp® Scientific Advisory Board (SAB). Dr. Lesko was Director of the Office of Clinical Pharmacology in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) for 16 years until his retirement in July 2011.

 a global Phase I to IV contract research organization, today announced the promotions of 

 to Executive Vice President, Clinical Development, General Medicine and Executive Vice President, Clinical Development, Central Nervous System (CNS), respectively, responsible for providing executive leadership for two of the Company’s therapeutic business units. The appointments reinforce INC's continued focus on providing customers with therapeutically specialized project teams to maximize efficiency and collaboration through proven expertise and strong business acumen. 

 the global biosimulation technology-enabled drug development company, today announced that its Director of Pharmacometrics 

 has been appointed an associate professor in the Faculty of Pharmacy at the University of Montreal. In this new role, Dr. Mouksassi will teach clinicians and students how biosimulation can be used to improve drug development and enhance health outcomes.

, a global biopharmaceutical services provider, today announced that its Board of Directors have elected 

 to the Board, effective August 26, 2015. Dr. Ho is a retired partner of the Goldman Sachs Group where she served as advisory director of Global Healthcare Investment Banking, as senior biotechnology analyst, and as co-head of healthcare for Global Investment Research.  

, a global CRO, functional outsourcing, and strategic staffing solutions provider, announced the creation of Advanced Clinical University and the addition of 

 Vice President, Clinical Operations Quality and Talent Development, to lead the new educational program. In 2013, CNN Money reported that Clinical Research Associates (CRAs) ranked number nine out of 100 ³Best Jobs in America².

, a full-services, international CRO providing clinical trial management services and appropriate solutions along the clinical trial value chain to the healthcare industry, with over 140 employees across Europe, expands its international business and announces the recent appointment of 

 as VP of Central and Northern Europe.  Klemens is biologist and biochemist by training, and holds an MSc in Biology, Biochemistry and Neuropharmacology from University of Konstanz, Germany (1988).

CTI Clinical Trial and Consulting Services (CTI),

 a multi-national, privately held, full-service contract research organization announces that 

 has joined as Executive Director, Global Human Resources and Richard Miller has joined as Senior Director, Business Development.

., a central IRB in customer service and technology, is pleased to announce its new office in the Research Triangle Park, Durham, North Carolina, is officially open for business. “We are thrilled to open the doors of our new space in RTP,” said Michael Woods, President, CEO and Institutional Official at Schulman. “Since breaking ground in June, we’ve all anticipated this day and are excited to start working even more closely with our new neighbors in the local life sciences community.”

magazine in their 34th annual Inc. 5000, an exclusive ranking of the nation's fastest-growing private companies. Avoca’s three-year sales growth of 165% earned the company its spot in the top 50% of the list.

, a provider of digital patient engagement and data capture solutions for clinical research and healthcare providers, today celebrates its recognition on the Sunday Times Hiscox Tech Track 100 – which ranks Britain’s fastest growing private technology companies.

Articles

New faces among the Pharma Industry rise the ranks.

Business and People: September 2015

	The Top 5 Risk-Based Monitoring Articles

	This slideshow encompasses the top 5 articles regarding 

. Risk-Based Monitoring is currently gaining steam as a new space among Clinical Trials and definitely deserves attention. These 5 articles will exemplify RBM and showcase the important highlights for Clinical Professionals to know. 

	For more information regarding Risk-Based Monitoring, visit our 

	Interested in meeting other Clinical Professionals regarding Risk-Based Monitoring, head over to 

CBI's own conference regarding Risk-Based Trial Management!

	A Structured Approach to Implementing a Risk-based Monitoring Model for Trial Conduct

	In today’s risk-aversive clinical trial environment, few clearly defined methodologies exist to aid sponsors and contract research organizations (CROs) in the identification, analysis and mitigation of monitoring risk factors for clinical trial conduct. Without a structured approach to model implementation, methodological variability may introduce process inefficiency, increased patient safety risk, increased operational expenditure and failure to improve overall trial quality and compliance. 

	An Alternative to Risk-Based Monitoring May Prove to be Beneficial

	While clinical trial data can indeed give some insight into safety and data quality, clinical trial data alone may miss certain issues. This is especially true with key indicators of site performance such as regulatory compliance and site engagement. All too often trial teams are caught off-guard by a site monitor's findings − when in fact − the issues could have been predicted using the right data analytics.

	Many biopharmaceutical enterprises are still coping with executing successful RBM pilots because of organizational challenges. BMS, for example, had to implement a change management program that focused on education and communication of a new set of roles and responsibilities in order to enable RBM.

	Risking It All? Introducing Risk-Based Monitoring at Cancer Research UK

	Though the U.S. Food and Drug Administration (FDA) released guidance on the expanded use of RBM in 2011, there was still reluctance on the part of sponsors to take on a full-scale risk-based approach. Many were concerned that failing to conduct 100% source data verification (SDV) could lead to something being missed and the validity of trial data being compromised. In general, sponsors had misconceptions about the potential benefits of identifying, targeting and reducing risk.

	The Current Status of Risk-Based Monitoring

	Risk-based monitoring (RBM) is garnering enormous attention as a change agent in the conduct of clinical trials. This reimagined approach to monitoring promises to reduce the time-consuming and costly practice of on-site 100% source data verification while refocusing efforts on improving data quality. Given this capability, use of RBM is being encouraged by the Food and Drug Administration as well as the European Medicines Agency. To evaluate the current status of RBM, Metrics Champion Consortium recently conducted an in-depth survey on the subject.

	For more information regarding Risk-Based Monitoring, head over to our 

	To connect with Industry Professionals in the Field of RBM, register for 

 The Top 5 Risk-Based Monitoring Articles 

 the global biosimulation technology-enabled drug development company, announced that it has appointed 

 to Senior Vice President of Human Resources.

., announced it has made two strategic new hires, one in product development and another in business operations. Joining the eClinical leadership team are 

Senior Vice President of Global Product Development and Technology, and 

 Senior Vice President, Business Operations.

 (MRN, is set for further expansion after a host of new hires in the UK and US. In the company's UK headquarters in Milton Keynes, the new starters include: 

 (Accounts, Purchase Ledger & VCMT Invoice Reconciliation). Meanwhile, in MRN's US office in Skokie, Illinois, 

, a provider of payment technologies for the clinical trials industry, announced the appointment of 

as Chief Financial Officer (CFO). With over 25 years’ experience in finance for market leading and start-up organizations across the software and technology sectors, Sue brings a wealth of specialist knowledge to the role.

CTI Clinical Trial and Consulting Services

, RN, BSN, MEd has been promoted to Executive Director, Study Management; and 

, MD, has joined as Medical Director, and will be based in Europe.

Laboratory Corporation of America® Holdings

as Chief Executive Officer of Covance Drug Development (Covance). Mr. Herring will retire on July 31 after more than a decade as CEO. Ms. Keller joined Covance in 1987 and has held senior leadership roles in global operations, quality assurance, and marketing over her tenure. 

, a service Clinical Research Organization

 announced the appointment of its new Chief Operating Officer, 

, who has been with the company for over 3 years. Shah will be located at the company headquarters in Mumbai, and, as a new COO, he will be responsible to ensure seamless delivery of SIRO’s integrated services of clinical operations, medical writing, clinical data management, biostatistics & programming, pharmacovigilance, and clinical trial supplies management.

PharmD, MBA joined as Director, Medical Information. With over 10 years’ experience in Medical Information and Regulatory within the biopharmaceutical industry, Amy Van Sant will take on the newly created role.

The Biomedical Research Alliance of New York (BRANY)

, the developer of Protocol Builder ®, is pleased to announce the appointment of 

as Senior Director of National Sales and Marketing. Mr. Olsen will be responsible for sales and marketing efforts with academic medical centers, health systems, hospitals and individual clinical investigators.

Pharmaceutical Product Development, LLC (PPD

 announced it has achieved CEO Cancer Gold Standard™ reaccreditation from the nonprofit CEO Roundtable on Cancer for maintaining a strong commitment to the health of company employees.

, a provider of digital patient engagement and data capture solutions for clinical research and healthcare providers, today announced that it has been granted a US Patent corresponding to its mDNA® technology.

 a global biopharmaceutical services provide, announced that the CEO Roundtable on Cancer named PAREXEL a CEO Cancer Gold Standard™ employer. 

 has recently passed a re-audit required by the BVMA, the Federal Association of Contract Research Organizations in Germany, to renew its certification to remain on the list of approved BVMA vendors in Germany. 

Business and People: August 2015

	This following list comprises all of our most popular Tweets from 2015. Find out what made the cut and read more about trending topics regarding Clinical Trials.

	Patient adherence is an emerging topic and a matter of concern in clinical research. Patient adherence can apply to several different clinical trial facets which may include adherence to study procedures, study visit compliance, medications, and adverse event reporting to name a few.
	 

	Europital announces the official launching and availability of its electronic platform Penthu® for managing medical issues in clinical trials. Penthu® is an innovative and intuitive platform that drives performance, knowledge and efficiencies in clinical trials.

Optimizing study protocols and improving data quality have been notable areas of focus in the biopharmaceutical industry; the total number of endpoints in a typical Phase III protocol increased from 7 to 13, the number of eligibility criteria rose from 31 to 50, and the number of investigative sites increased from 124 to 196, yet the total number of patients randomized declined from 729 to 597 from 2002-2012, respectively.

	ResearchKit is Apple’s foray into clinical research based on the backbone of its 

 released  in June 2014, which offered the ability for health and fitness apps to communicate with each other. mHealth News reported Apple CEO Tim Cook said, “As we worked on HealthKit, we came across an even broader impact that iPhone could make, and that is on medical research.”

The SiteCloud platform is the same technology used by TransCelerate’s Investigator Registry and the Investigator Databank. Using  a universal identifier within the platform allows INC to match data from numerous disparate sources.

	After decades of promise, we have begun to realize the fruit of “-omics” technology. Recent advances in proteomics, genomics and metabolomics have enabled us to understand the molecular basis of disease at both the diagnostic and treatment levels. Equally important, a growing suite of biomarkers now provides predictive value for diagnosis, disease progression and cure/remission.

Satisfaction surveys provide clinicians valuable insight into quality-of-care metrics. However, in order for satisfaction surveys to be most useful and yield meaningful results that can improve patient outcomes and well being, the responses must be truthful and accurately reflect the respondent’s inherent satisfaction. To achieve this goal, it is important that the survey be constructed and administered properly.

Drug development has never before been so difficult, time consuming and expensive. Accuracy in clinical trials, therefore, is a priority. However, suboptimal adherence is prevalent in ambulatory trials, in which outpatients are responsible for taking the drug according to the protocol-specified dosing regimen.

	That intriguing question raises important issues about how widespread patient sharing of information over the Internet can both support and undermine efforts to obtain meaningful results from biopharmaceutical research studies. Disease group chat rooms, instant messaging and Facebook pages can help recruit patients to clinical trials and make them feel part of a community making an important contribution to health and science.

 This following list comprises all of our most popular Tweets from 2015. Find out what made the cut and read more about trending topics regarding Clinical Trials.Follow @Clin_Trials for more information!   

The Top Ten Tweets of 2015 (So Far)

Mark Paul as Senior Vice President, US Operations.

 He will be responsible for the company’s U.S. operation and will represent U.S. interests on the global leadership team. Mr. Paul brings significant experience to the position having served in senior management roles at Quintiles, Health Decisions, StatWorks, and most recently Veracity Logic.

, said, “I am delighted to welcome Mark to our company. We are growing our customer base in the United States and increasing the size of our group here. Mark has great experience in delivering global projects and in growing and developing operational teams. He will oversee our continued growth in the region and will work closely with our customers to ensure they receive the highest levels of service”.

, a global drug development strategist specializing in the 

 Marc Wiles, Ph.D., as Vice President, scientific and regulatory affairs, and Suzanne Beck, J.D., M.P.H., as director, contracts and legal projects

. With more than 20 years of experience in drug development, Wiles brings extensive technical and regulatory expertise to Camargo in assessing, developing and registering therapeutic products. He has demonstrated success across the full life cycle of pharmaceutical product research, development and regulatory affairs in Europe and the United States, with considerable interaction with regulatory agencies.

Senior Vice President, Business Development for Ashfield Market Access. 

In this role, Mr. Burrus will be responsible for identifying new business opportunities and ensuring the successful execution of key client projects.

 a global life sciences consultancy and technology provider, today announces the appointment of 

 to shape a “Talent Team” that focuses on internal consulting and service delivery -- not simply administration efficiency and compliance. With 20+ years of experience, Astringer draws upon his considerable experience and knowledge to promote the Alliance employment brand, engage employees and oversee talent acquisition strategies. 

Vice President of Global Client Development

John Fulton was named Director of Global Client Development;

Courtney Klauber joins as Marketing Associate.

, a global provider of patient safety and efficacy endpoint data collection, cloud analytics and workflow solutions, today announced the appointment of 

Steve Nuckols to the position of Executive Vice President and Chief Commercial Officer

 (CCO). As CCO, Nuckols will be responsible for all global business development activities within ERT, with primary focus on ensuring ERT’s products and services best meet the needs of its global pharmaceutical customers.

 (CTI), a multi-national, privately held, full-service contract research organization announces the promotions of 

Dr. Günter Stetter and Sibylle Lawson. Dr. Günter Stetter has been promoted to Senior Director of Clinical Operations,

 Europe, where he is responsible for overseeing the clinical operations for all CTI European offices and work taking place throughout the continent.

 Sibylle Lawson has been promoted to Assistant Director, Clinical Trials

, where she will continue to oversee global clinical studies across a variety of disease indications.

. Jonathan Dole, CEO and co-founder of endpoint stated: "We are extremely pleased to announce Chuck's promotion. In this role, Chuck will be responsible for the execution of endpoint's mission to deliver a highly customizable, fully configurable SaaS IRT offering to our global customer base." Chuck has provided quality and operations leadership in the IRT industry for more than 14 years, having most recently served as endpoint's director of product development.

, the global contract development and manufacturing organization, today announced the appointment of a new Vice President at its Craigavon and Souderton Headquarter facilities. 

Vice President of Quality Operations at its 

 based in the UK, which offers API and chemical development services for all stages of drug development. 

 to its growing staff of pharmaceutical experts. Among his other duties, 

 is responsible for the formulation and process development of early-phase oral dosage forms, and oversees the manufacture of clinical trial materials to support client-sponsored research studies.

., a central IRB in customer service and technology, announces 

. Additionally, Absolute Research founder Rebecca Ballard will be joining the Schulman team as Vice President of Compliance and Board Operations. The transaction allows for significant investment to expand Absolute Research’s innovative technology offerings for the clinical research community, and Ms. Ballard’s substantial research ethics and legal expertise, as well as her leadership experience in the institutional research setting, bring valuable perspectives and knowledge to the organization.

, a SaaS-based eClinical technology company that supports the entire spectrum of clinical research, is pleased to announce 

 the company's intuitive, flexible and affordable cloud-based eClinical technology platform, has been 

awarded a Silver 2015 Stevie® Award by the 

(SM) in the Health Products & Services Website category. 

 The American Business Awards are considered the nation's preeminent business awards program.

New faces among the Pharma Industry rise the ranks

Business and People: July 2015

continues to attract pharmaceutical industry visionaries to join its mission of developing innovative clinical technology solutions to help sponsors, CROs and sites do more trials together. Today, the company announced 

 a distinguished team of current and former clinical research executives from many of the leading pharmaceutical companies in the world.

Alberto Grignolo, PhD, Corporate Vice President, PAREXEL Consulting

. The honor recognizes Dr. Grignolo's meritorious service through a leadership role that has advanced the mission of DIA to foster innovation and to improve health and well-being worldwide. At PAREXEL, Dr. Grignolo developed the Company's Worldwide Regulatory Affairs and Drug Development Consulting Practice. Recently, he established PAREXEL's Japan Consulting Services during a two-year assignment in Tokyo. He is the Executive Sponsor of a number of global development programs and advises clients in the areas of drug development strategy, regulatory negotiation, and best regulatory and clinical practices. 

 promoted to Executive Director, Study Management

 promoted to Senior Manager, Business Development Operations

 a specialty clinical trials services and technology provider, today announced that 

David Peters, an accomplished senior finance and accounting executive, has been named Executive Vice President and Chief Financial Officer (CFO) and will be joining BioClinica on June 8, 2015.

	Peters brings more than 25 years of financial and accounting experience with a focus in pharmaceutical services. “David has extensive and deep knowledge in all areas of finance, accounting and business operations and understands the specifics of our high growth and diverse business segments in both private and public markets, making him well-suited for the position,” said BioClinica CEO John Hubbard, Ph.D.

, a full-service clinical research organization (CRO), is pleased to announce the hiring of 

Vice President of Global Business Development for the Clinical Trials Division.

 Bagshaw will be responsible for leading strategic corporate and business development efforts internationally. “Jeff is a proven leader in business development and clinical operations,” said Dr. Robert Reardon Ph.D., Chief Operating Officer at TKL. “This unique combination gives him an exceptional ability to understand client needs and will help us tailor our offerings for rapid enrollment and high-quality clinical research.”

President, inVentiv Health Clinical Division and Executive Vice President, inVentiv Health

. Previously, he served as Executive Vice President and Chief Operating Officer at Aptiv Solutions, a global clinical development services company.

, a contract research organization focused on bringing new products to market through a full range of product development services, recently announced that its 

Chairman and Co-founder Ronald W. Helms has been inducted as a Fellow of the Society for Clinical Trials. 

The Society established the title of “Fellow of the Society for Clinical Trials” (FSCT) in 2005 to honor Society members who have made significant contributions to the advancement of clinical trials and to the Society. The SCT Class of 2015 Fellows were announced during the SCT 36th Annual Meeting, which was held at the Hyatt Regency Crystal City, in Arlington, Virginia, on May 18.

	Following the completion of the management buyout of 

the new board confirms its intention to expand the footprint of the company through organic growth and acquisition. Synexus, already a multi-national company dedicated to the recruitment and running of clinical trials at its own research centers across the globe, intends to become a major player in the US, continue to expand its existing network of sites in Europe and Africa and develop a presence in Asia and South America.

The new board members of Synexus are: Chairman Charles Woler and non-executives Benjamin Harrild, Hywel Evans, Ged Gould and Simon Braham.

 CEO of Synexus, Christophe Berthoux, and Financial Director of Synexus, Paul Chambers, will remain on the board.

 a contract research organization focused on bringing new products to market through a full range of product development services, recently announced that the company 

was recognized as one of the Best CROs by the Triangle Business Journal

, a multimedia source for local business news, research and events in the Raleigh, Durham, Chapel Hill region of North Carolina, where Rho is headquartered.

 will showcase detailed findings from more than 60 clinical trials at the 

51st Annual Meeting of the American Society of Clinical Oncology (

), held May 29-June 2 at McCormick Place in Chicago.

 These data presentations cover novel approaches to numerous types of cancer specialties including breast, bladder, blood and lung cancers as well as promising immunotherapy research.

CTI Clinical Trial and Consulting Services, 

a multi-national, privately held, full-service contract research organization announces that 

Timothy J. Schroeder received the EY Entrepreneur of the Year™ 2015 Award in the services category in the Ohio Valley Region. 

The awards program recognizes entrepreneurs who demonstrate excellence and extraordinary success in such areas as innovation, financial performance and personal commitment to their businesses and communities.  Schroeder was honored, along with the 30 other finalists selected by a panel of independent judges, at the award ceremony on Thursday, June 4, 2015.

a provider of cloud-based clinical study startup solutions, announced today that the company has been included in the 

Cool Vendors in Life Sciences, 2015 report,

 published by Gartner, Inc. Gartner's Cool Vendor research "is designed to highlight interesting, new and innovative vendors, products and services."

 inclusion in the Cool Vendor report by Gartner confirmation of our mission to be the world's leading cloud-based study startup platform," 

 "Industry leaders in clinical trials continue to show strong adoption of our flagship product, goBalto Activate. Our solution is now being used in hundreds of studies in multiple countries at over 16,000 sites – enabling medicines to get to those in need faster."

 a central IRB in customer service and technology, recently 

began build-out of its new office space on Laboratory Drive in Research Triangle Park, Durham, North Carolina. 

The location will house review board and administrative staff, including IT, operations and customer service professionals. “This new office enables Schulman to be closer to many of our clients and will help us better serve the research organizations located in this vibrant life sciences community,” said Michael Woods, President, CEO and Institutional Official at Schulman.

Regional Hub Office for Sub-Saharan Africa, with opening of new larger office premises in Johannesburg, South Africa.

  Aligning with new client partnerships, the office will support region wide clinical research services including a significant new clinical FSP assignment with a global biotechnology major where ClinTec is the sole FSP partner for South Africa.  “ClinTec has a track-record of aligning its investment programme with strategically important client needs.  Our continued investment in South Africa over the last 5 years demonstrates a consistent effort to address high-potential markets for clinical research” said Bobby Bal, Executive Vice President.

Miraj Barodia

Articles

Business and People: September 2015

The Top 5 Risk-Based Monitoring Articles

Business and People: August 2015

The Top Ten Tweets of 2015 (So Far)

Business and People: July 2015

Business and People: June 2015