In this Q&A, Sameer Tandon, head of strategic alliances and customer transactions in U.S. medical affairs for Novartis, shares some of the challenges of his job and what trends will shape the future of the medical affairs group. Tandon discusses real-world evidence, FDA, payers, working with CROs, procurement costs, and more.
At Bioclinica, we are proud to provide our clients with scalable financial lifecycle solutions that can handle global payments as well as integrate with any EDC, CTMS and RTSM. As of April 4, 2016, we've helped Sponsors and CROs make $285 million in payments to 9,012 sites with 70,972 subjects in 63 counties. However, although our technology is a huge factor in our clients' successes, we wouldn't be nearly as successful without the extensive clinical trial expertise that our team members bring to the table. Our team has experience in many facets of clinical trial management, whether from a CRO, Sponsor or technology perspective. They've been able to leverage that experience in order to help our clients navigate the most challenging aspects of the clinical trial financial lifecycle so they can seamlessly automate financial management and improve site satisfaction.
Understanding the clinical and technical factors surrounding a product during development is critical for downstream success. John D. McDermott, Jr., Vice President, Covance Market Access Services, discuses approaches to maximize a product’s commercial value.
Clinical Leader relies on the feedback of pharma industry professionals and consultants to guide its focus and direction. The website’s editorial advisory board, composed of consultants and executives from the pharma and bio industries, help guide the direction and focus of the site’s editorial content. Clinical Leader has announced that in 2015 it added 17 distinguished individuals to that board, including representatives of Eli Lilly and Company, Pfizer, The Avoca Group, PatientsLikeMe, BMS, Novartis, Shire, and more.
PCI is an integrated full service provider and a trusted partner to leading companies in the global healthcare industry; we offer unparalleled expertise and experience in taking compounds from the earliest stages of development through to commercial launch, delivering speed to market and commercial success for our customers. Core services include: Analytical services, formulation development, clinical trial supply, commercial manufacturing and packaging, QP services, supply chain management, storage and distribution.
Post-approval research studies are becoming increasingly large and complex in the clinical research landscape. These programs are often massive in scope, engaging thousands of physicians and tens of thousands of patients. Unfortunately, post-approval operational strategies have not kept pace with the needs and demands of post-approval (Phase IV) research.
If your business is like many other pharmaceutical, biotech or medical device companies, your investments in post-approval research are steadily increasing. Discover how to harness the power of post-approval research to increase data collection, reduce resource burn, save money, and maximize your ROI!
As a result of our holistic approach to Late Stage clinical programs and with our expertise in Product Life Cycle Management, INC Research/inVentiv Health is strategically positioned to collect real world, differentiating product evidence that can prepare our clients to more successfully go to market.
We’ve invested in a strategic mix of proprietary services and infrastructure that offers each client customized solutions through a singular team to thrive in the new market reality.
At INC Research/inVentiv Health, we are reinventing the way our oncology clients commercialize products to optimize performance, reduce risk, and expedite the delivery of healthcare innovation to patients worldwide. In the last five years, we have conducted over 250 full-service oncology programs in more than 65 countries.
DATATRAK International, Inc. (OTCQX: DTRK), a leader in developing cloud-based, unified eClinical® technologies and delivering related services for the clinical trials industry, today announced its operating results for the first quarter of 2013.
inVentiv Health, Inc., offering best-in-class clinical, commercial and consulting services to the healthcare industry, recently announced that inVentiv Health had been rated a Top CRO in a bi-annual survey by CenterWatch, a leading provider of global clinical trial information.
OsoBio has named David M. Lee vice president of quality.
Lee is responsible for overseeing all quality-related functions to ensure the company’s continued compliance with Current Good Manufacturing Practices (cGMP), including quality systems, quality control and manufacturing quality assurance.
Lee brings to his role more than 20 years of professional experience managing quality operations and API and sterile manufacturing.
Chiltern International Limited (Chiltern), a global contract research organization (CRO), announces the appointments of Dr Manuela Niewel and Lisa Bull to secure Chiltern’s continued success and future growth.
Chiltern International Limited (Chiltern), a global contract research organization (CRO), announces the promotions of Stuart McGuire and Jim Szymeczek.
INC Research, LLC, a therapeutically focused global clinical research organization (CRO) with a Trusted Process® for delivering reliable results, today announced James Taylor has joined the Company as Vice President, Clinical Development. Mr. Taylor joins INC Research from Pfizer, where he served most recently as Vice President, Global Clinical Trial management. In his new role, Mr. Taylor will serve as the primary liaison to biopharmaceutical customers, vendors and investigative sites for the Company's General Medicine Business Unit.
Exco InTouch, the leading provider of patient engagement, data collection and communication solutions for the pharmaceutical and healthcare sectors, recently announced that it has joined the Electronic Patient-Reported Outcome (ePRO) Consortium, a programme run by the Critical Path Institute (C-Path), which strives to enhance the quality of patient reported outcomes (PRO) in the evaluation of new pharmaceuticals.
inVentiv Health, Inc., offering best-in-class clinical, commercial and consulting services to the healthcare industry, recently announced that, at a ceremony in London, inVentiv Health was named “Clinical Company of the Year” by PharmaTimes.
Stiris Research has entered into a strategic partnership with Statistics & Data Corporation (SDC) to offer seamless implementation of full-service Clinical + Biostatistics and Data Management/EDC solutions.
Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced a non-exclusive collaboration with Janssen Pharmaceuticals, Inc. for the clinical development of all-oral direct-acting antiviral (DAA) HCV combination therapies.
Clinical Research Management, Inc. (ClinicalRM), a full-service Contract Research Organization providing services for basic and applied research, clinical trials, and regulatory support, announced today it was awarded a USAMMDA contract.
JHP Pharmaceuticals, a provider of global contract manufacturing services for sterile products has entered into an agreement with an undisclosed pharmaceutical company to produce supplies of a lyophilized biologic for international, late-phase clinical trials.
INC Research, LLC, a therapeutically focused clinical research organization (CRO) with a Trusted Process® for delivering reliable results, recently announced the opening of a facility in South Korea to manage the growing demand for world-class clinical development programs. Located in the heart of Seoul's business district, the Company's South Korean team is primarily focused on study start-up and clinical operations activities around key therapeutic areas.
DATATRAK International, Inc. (OTCQX: DATA), a technology and services company focused on global eClinical solutions for the clinical trials industry, today announced the award of a multi-million dollar, five-year technology and services agreement with Bellicum Pharmaceuticals.