Webcasts - Applied Clinical Trials

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Regulatory Challenges in Global Biosimilars Drug Development
March 13, 2012 at 11:00 AM EST

Regulations for biosimilars are currently evolving in Europe, the United States and many emerging countries. Europe has been in the forefront of biosimilar regulation since 2001 when the EU created a pathway for the approval of biosimilars. Companies seeking to establish a point of entry to or maintain a position within the biosimilar marketplace must first identify the requisite regulatory requirements for every intended market. As guidelines and pathways around the world continue to mature, the complexity of this exercise cannot be understated. This process needs to follow a logical step-wise progression to ensure that, where possible, a global development plan can be developed to satisfy regulators in each potential market. The regulatory and commercial considerations are the primary drivers for successful biosimilar development, because speed-to-market is critical.

Sponsor:
PRA International

New Drug Approvals Lacking in Lupus Clinical Research: Are effective study design and endpoint selection to blame?
March 26, 2012 at 11:00 AM EDT

The focus on SLE Clinical Research has surged over the past ten years, particularly with the development of Standardized Efficacy Indices capable of measuring disease activity and patient response during clinical trials. RPS welcomes you to join them for an Interactive discussion with Lupus Industry KOLs while deconstructing past and current clinical trials, inclusive of study design and the application of the current tools available to today?s clinicians to assist in the successful development of investigational products that provide an improved quality of life for those affected by this devastating disease.

Sponsor:
RPS

eClinical Choices for Small to Mid-Size Companies
April 24, 2012 at 11:00 AM EDT

There is no doubt that that using an integrated approach to eClinical software within an organization can streamline efficiencies and improve decision-making. However, smaller pharma and biotech companies struggle to choose eClinical products that can meet their needs at the right price. This webcast offers information on the current state of the overall eClinical market, how the moves among vendors are impacting the small to mid-size pharma and biotech, and how these sponsors are making their eClinical buying decisions.

Sponsor:
Applied Clinical Trials

ON-DEMANDS NOW AVAILABLE FOR REPLAY

Current Issues in Cardiac Safety
Recorded on: November 17, 2011

Cardiovascular safety and outcomes for all drugs in development is a pivotal issue toward approval. Many non-cardiovascular products, including Meridia, Vioxx, and Avandia, and others have been voluntarily withdrawn by sponsors, or withdrawn by the FDA for cardiovascular safety issues. Others, such as Chantix, have undergone expanded safety labeling to inform the public at large about heart safety issues related to these prescription drugs. This Webinar will focus on how cardiac safety and its measurement have become a key consideration in clinical trials, especially in regard to the QT segment and when and how to screen for that CV signal.

Sponsor:
PPD

The Future of Pharma: What you need to know about observational studies to succeed in a global marketplace
Recorded on: November 8, 2011
What is the pharmaceutical marketplace today and why do you need to conduct more observational studies and registries to be successful? This webcast will explain the requirements for observational study data as part of using observational studies in market access strategies. We will also discuss how to successfully address challenges in setting up and running large observational studies in North America, South America, Europe, Africa, the Middle East and Asia. Funding models - advantages of different approaches for different types of studies, including those of single sponsor, multi-sponsor, subscription mode and Independent research grants, will also be discussed.

Sponsor:
Registrat-Mapi

Achieving 100% Paperless eClinical Processes with Digital Signatures
Recorded on: November 2, 2011

In this session, attendees will learn how digital signatures can be applied in eClinical applications to enable secure electronic document exchange, timely reporting, and regulatory compliance in a collaborative environment. We will also discuss how digital signatures speed study and site initiation, automate site monitoring reporting, and support regulatory compliance.

Sponsor:
ARX

Bringing Biosimilars to Market
Recorded on: September 21, 2011

With the original biologics developed for marketing now coming off patent, the generic biologics--or biosimilars--market is expected to grow 89.1% between 2009 and 2014. Coupled with an established biologics approval pathway in Europe, and FDA guidance on biosimilars still forthcoming, sponsors are looking for both clinical development and regulatory expertise to bring these products to market. This Webinar will include an update on approval pathways in the United States, as well as what is happening on the global biosimilar space. Ethics in biosimilar clinical trials, as well as cost projections of a biosimilar trial vs. a traditional drug trial will be explored.

Sponsor:
Applied Clinical Trials

Understanding the New EU PV Regulations
Recorded on: September 29, 2011

The EU recently adopted new pharmacovigilance (PV) legislation, much of will be in effect by July 2012. Experts agree that PV and regulatory professionals should not wait until the last minute to address the new legislation. To that end, this Webinar will provide insight, best practices, tips and advice on how to implement and adhere to the new EU PV legislation.

Sponsor:
Applied Clinical Trials

Strategies in Successful Early Phase Development
Recorded on: July 21, 2011

Many drivers are moving pharmaceutical sponsors to make earlier decisions on drug compound development. Factors that make a difference on the go/no-go decisions made earlier in drug development are influenced by trial design and the incorporation of personalized medicine, biomarkers, and various tests for potential safety issues. This Webinar will focus on describing these factors, examples of their successful use, as well as well as best practices for adoption.

Sponsor:
Applied Clinical Trials

Oncology Clinical Trials: Keys to Approval
Recorded on: June 14, 2011

The event will educate the audience on the status of Oncology Drug Development and why increasingly drugs in this therapeutic area are difficult to be approved. By addressing the key issues in clinical trials, biopharmaceutical sponsors could experience higher quality data in trials leading to better drug approval outcomes. Understand how alternative therapies impact data quality and subject behavior in oncology trials. Understand how current oncology drug developments in diagnosis and biomarkers positively impact clinical trials. Understand current oncology drug development barriers and best practices to overcome them.

Register Free at www.appliedclinicaltrialsonline.com/approval

Sponsor:
PPD, Inc.

Leveraging SharePoint to Maximize CTMS Adoption and Flexibility
Recorded on: May 11, 2011

SharePoint is the fastest growing product in Microsoft's history and its developer community is growing quickly. In the beginning, SharePoint was simply a collaboration platform, but it has evolved throughout the years to become what it is today; an integrated suite of server features including: content management, enterprise search, business connectivity services, and information management. With such powerful capabilities, the SharePoint application landscape ranges from simple web part solutions over business collaboration applications to sophisticated applications for integrating Line of Business (LOB) data. Les Jordan, CTO, Life Sciences Industry Unit at Microsoft, will discuss how SharePoint can help companies manage their clinical operational data to collect more timely information and to make more informed decisions. Bob Leonard (HCRI) will discuss the benefits HCRI has seen from surfacing clinical operations data through SharePoint via their CTMS system, and how they use SharePoint to connect to Microsoft Office applications for improved data visibility and control.

Sponsor:
BioClinica

How the Technology Challenge Has Changed and What it Means to You
Recorded on: May 24, 2011

As clinical development generates and relies upon ever-growing volumes of data, becomes more global in scope, and regulatory scrutiny continues to escalate, trial sponsors are looking for new ways to accelerate the return on investment for clinical research. But managing the flow of information has become increasingly challenging as R&D has become more virtualized and networked, and technology now originates from a disparate variety of sources for multiple purposes. Without transparency and control, sponsors struggle to maintain an audit trail, eliminate duplicate or outmoded processes, and streamline data analysis and regulatory submission. To achieve maximum efficiencies it is vital to move away from individual point solutions that are costly and challenging to integrate, and integrate the whole end-to-end clinical environment.

Oracle provides the world's broadest set of integrated life sciences applications that enable pharmaceutical companies to automate the management of their entire clinical development process- from Phase I through Phase IV. Join Oracle Vice President of Strategy Martin Young for an overview of Oracle's integrated life sciences applications and learn how they help drive efficiencies by integrating both data and workflows.

Register Free at www.appliedclinicaltrialsonline.com/productivity

Sponsor:
Oracle Health Sciences

Enhancing Clinical Operations with Digital Signatures
Recorded on: April 13, 2011

In this session, attendees will learn how digital signatures can be applied in clinical operations to speed study and site initiation, automate site monitoring reporting, enhance investigator portals, and support regulatory compliance. We will also discuss how digital signatures enable secure document exchange and electronic submissions.

Sponsor:
ARX

Using Web-Based Capture in Late Phase Research and Patient Registries
Recorded on: March 9, 2011

FDA mandates for increased post-approval surveillance and demands from payors and providers for evidence of the benefits of new treatments have placed increased emphasis on the quality of data gathered in post-market research. Paper-based forms are slow, ineffective and expensive, and traditional EDC solutions, developed for investigator site collection, do not meet patient requirements. Utilizing electronic patient reported outcomes (ePRO) technology offers sponsors a more accurate and cost-effective solution for conducting these large and lengthy post-marketing studies. The event speakers will detail some of the drivers behind the rise in late phase research and the need for global registries, and describe strategies to increase patient compliance. The challenges of global trials, where patients and sites report in their native languages, collecting data in a naturalistic setting, and integrating data collected from patients and sites will also be discussed.

Sponsor:
Oracle Health Sciences