Newsletter | November 30, 2020

11.30.20 -- Ensuring Patient-Friendly Clinical Trials For Complex Disorders: A Small Biopharma's Playbook

 
Sponsor
Focus On Patients
Embracing Diversity And Inclusion
Industry Insights
Mitigating Inherent Risks In Global Sample Processing

The global demand for specialized sample processing has grown dramatically; however, despite the rising need, research teams continue to struggle to obtain high-quality laboratory support services to perform sample processing. Learn how innovative flow cytometry’s fast turnaround and monitored, specialized processing can help safeguard samples.

Who’s The Boss? Responsible Parties And The TMF

Depending on the number of sites and duration of the study, a single trial master file (TMF) can have upward of 500,000 documents. Many companies grapple with who is really the boss and what authority they have to make sure they are carrying out the necessary activities to ensure smooth operation and that each “family member” puts things in the correct place. This lack of centralization can hamper a sponsor’s ability to keep the TMF/eTMF as “complete,” “comprehensive,” and “contemporaneous” as required by the regulatory authorities and can create risks.

The Trials Of The Future Are Needed Now

A paradigm shift is under way in the world of clinical trials as more and more CROs and pharma companies investigate some type of decentralized trial. The adoption of novel approaches has been slow, but the COVID-19 pandemic has changed everything.

Exploring Clinical Trial Design And Data Collection In A New Environment

New research reveals that COVID-19 has accelerated adoption of decentralized approaches and remote data collection for clinical trials and that this transition has come with both challenges and benefits.

Pharma’s Digital Awakening: Research-Ready Health Information And AI To Reduce Cost And Deliver Better Treatments

Digital innovations and their emerging technologies, such as artificial intelligence (AI), advanced analytics, and cloud-based computing, are transforming industries and markets across the world as they offer novel ways to boost R&D, increase product quality and safety, and, ultimately, improve customer satisfaction.

Accelerating Clinical Trials: The New And Future Normal

Inefficient interactions between clinical trial stakeholders play a large role in the time to bring a new drug to market. The pandemic is forcing this to change, and the shared investigator platform (SIP) is facilitating these efforts.

Behind The ADAPTABLE Study, The Largest Decentralized Clinical Trial To Date

A web-based application remotely manages the informed consent process, enrollment, and randomization of ADAPTABLE participants while allowing them to easily report their health outcomes throughout the study from the comfort of their homes.

Top 10 Global Pharma Company Dramatically Improves Site Payments In Drive To Become Sponsor Of Choice

Investigative sites performing studies on behalf of pharma companies often operate on tight profit margins and need to get paid on time. This Top 10 pharmaceutical company understood that becoming the sponsor of choice for sites around the world was a competitive differentiator.

Top Tips For Preventing Customs Chaos

See how selecting the right importer of record (IoR), getting an early start, following the rules, perfecting the paperwork, and knowing the numbers can streamline your customs process.

Improving Clinical Logistics Outsourcing Relationships

In Q3 2019, ISR asked 100 outsourcers of clinical logistics about several different scenarios that could potentially improve outsourcing relationships. Two scenarios were considered Very Likely – Likely to improve relationships by 75% of respondents: improved technology integration and improvements to project management from both the sponsor and service provider.

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