ACT

JANUARY 23/2018


news roundup

ANVISA Adopts Certara’s Phoenix Software for Drug Regulatory Reviews

Certara announced that the Brazilian National Health Surveillance Agency, ANVISA is now also employing Certara’s Phoenix WinNonlin software for reviewing drug regulatory submissions.


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Considerations for Efficient Site Contracts and Payments
Clinical trial agreement development has a tremendous impact on study start-up – integrating site-level budgets, payment terms, and Clinical Trial Management Systems set-up. By understanding the most important considerations for contract development and budget planning, you can execute a fully-integrated process that results in high-efficiency enabled contracts and payments.
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Latest Business and People News

Updated employee announcements, business news, awards, and recognition in the industry today.


Celerion and OmniComm Systems Announce Five-Year Strategic Partnership

A collaborative, solutions-driven partnership, featuring end-to-end support of clinical trials is now underway between Celerion and OmniComm Systems, Inc.


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The Benefits of a Data-driven Approach to Feasibility
Live Webcast: Tuesday, March 20 at 11:00am EDT
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YPrime and CompleWare Announce Partnership Agreement

With the combination of Compleware’s eClinical software and service solutions along with YPrime’s collection of clinical data and their IRT offering which manages clinical systems, they have announced a partnership agreement to deliver enhanced service offerings.

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In this edition

Latest Business and People News
Mitigating Risk in Implementing Multi-Regional Trials in Multiple Sclerosis
Janssen Develops Analytical Vendor Oversight Model
The Risk Based Monitoring Plan

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Events

Clinical Data Disclosure and Transparency
EFGCP Annual Conference 2018
Clinical Trial Budgeting & Forecasting
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Articles

Sponsors Ask: Is Our Trial Plan Realistic? Toward a Data-Driven Feasibility Assessment

Today, a data-driven approach to feasibility assessment can help ensure that a sponsor’s clinical research plan is designed to enroll the right patients, rely on the right investigators, and take place in the right countries for success.


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The Rare Disease Revolution
Live Webcast: Thursday, January 25 11:00am EST
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Mitigating Risk in Implementing Multi-Regional Trials in Multiple Sclerosis

Examining the main challenges in designing and executing MS clinical trials and proposing mitigation strategies that may help alleviate these burdens.

Blog Posts

TransCelerate: Perspectives for Addressing Patient-Clinical Trial Access Opportunities

In this interview, Christa Polidori, Clinical Trial Disclosure Manager at Bristol-Myers Squibb and a leader for the TransCelerate Clinical Research Access and Information Exchange Initiative, will discuss the TransCelerate proposal in greater detail.


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Research Reveals a Need for Evolution in Randomization and Trial Supply Management (RTSM) Technology
On Demand
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Janssen Develops Analytical Vendor Oversight Model

Kristy Galante recently spoke about a novel vendor oversight model at ExL’s 8th Clinical Quality Oversight Forum, and will expand on the model in this interview.


RBM

The Risk Based Monitoring Plan

Sponsors and CROs are looking into implementation of a Risk Based Monitoring approach to their clinical trials to achieve the objectives related to enhanced data quality, better monitoring of patient safety, and creating efficiencies in overall operations.


 

Beyond RBM: How Intelligent Analytics are Being Used to Drive Value and Support ICH Compliance

Steve Young looks at the tremendous benefits that organizations stand to reap by effectively implementing the core principles included in the ICH update and the significant opportunities that the application of intelligent analytics and centralized statistical monitoring may present.


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Lisa Henderson
Editor in Chief
Lisa.Henderson@ubm.com

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Todd Baker
Group Publisher
todd.baker@ubm.com