Newsletter | October 31, 2022

10.31.22 -- Effective Medical Communications During CGT Clinical Trials

Featured Editorial
Industry Insights
How Continuous Improvement Ethos Serves Patients And Clients

Years of experience, bolstered by continuous improvement efforts, have positioned MRN at the forefront of decentralized clinical trial execution, from in-home care to the MRN eClinical suite of technology.

Mitigating Trial Risk In ALS Clinical Development

The development of new treatments has been slow, with only two approved disease-modifying drugs that offer limited benefit. But significant advances in immuno-neurology have set the stage for promising novel treatments that could offer hope to these families and change the course of this disease.

Drug Safety And Product Protection Driving Blister Packaging Growth

Learn why the trends in the packaging of prescription and over-the-counter drugs indicate continued growth in the blister packaging market. 

Fixed-Dose Combination Drug Development: Designing A Lifecycle Strategy

Combining drugs that may have been shelved due to a variety of reasons with established, safe, and approved drugs has the potential to bring safer, effective therapies to patients.

Real-World And Late-Phase: Making The Switch From Rx To OTC

Given the right expertise, Rx-to-OTC conversions are easier to achieve with less time and expense than one might expect for a regulatory exercise.

Featured Editorial
Industry Insights
A Unified eClinical Ecosystem For “Trusted Collaboration”
The outsourcing trend is being driven in response to the ever-increasing size, complexity, duration, and cost of clinical trials. Sponsors primarily outsource to CROs to control operational and infrastructure costs, allowing them to concentrate on what they do best — drug development. However, with outsourcing, processes and systems are often duplicated or disparate. You need a unified eClinical ecosystem for “trusted collaboration.”
5 Patient Engagement And Recruitment Trends And How To Keep Up With Them

From decentralized trials to real-world data, take a look at top trends, their impact on patient enrollment and more, as well as ways to stay ahead of the curve.

3 Simple Steps To Manage Multiple Protocol Versions In A Single Study
Managing protocol versions at the site level and the broader protocol amendment at the sponsor level go hand in hand. Learn why neither is simple, but both sides of the equation must be taken into consideration when designing a study.
Collaboration Requirements For An eClinical Supply Chain Management Platform

Discover how an eClinical supply chain management (eCSCM) platform is crucial in order to replace manual processes and have capabilities that streamline the coordination of collaborators and the communication between them.

Remove Financial Toxicity From Oncology Trials With Patient Reimbursement

In this webinar, learn what sites, CROs, and patient advocacy groups are doing to make clinical trials accessible to more patients.

Industry Insights
Complete SDTM Activities Without Sacrificing Speed, Cost, Or Quality

How can sponsors ensure SDTM compliance while still maintaining the efficiency and speed necessary to meet their trial timelines and milestones?

Phase II/III Outsourcing Partner Selection Attributes

In Q1 and Q2 of 2022 ISR surveyed 132 sponsors worldwide who outsource Phase 2/3 studies and asked them to identify attributes that are important to them when selecting an outsourcing partner. The research revealed that respondents valued Operational excellence and Therapeutic expertise highly when choosing a provider for their Phase 2/3 studies. To learn more about outsourcers’ Phase 2/3 study needs, market dynamics, and their use of different service providers.

Drive Change In Cell And Gene Therapies: Learnings From The SITC Summit

Chris Learn, head of cell and gene COE at Parexel, discusses his participation at the recent Clinical Research Virtual Summit hosted by the Society for Immunotherapy of Cancer, and the implications for clinical research.

Clinical Development Strategies For Western Biotech Companies In China

Delve into how China is now more aligned with international standards, especially the U.S. FDA, enabling biotech firms to streamline processes and timelines, which has significantly recharged biotech innovation.

Understanding The Scope And Pain Points Of Study Start-Up Part 2: The Evolving EU Landscape

In this webinar, review some key changes to the European Union regulatory framework, in particular the EU Clinical Trial Regulation (EUCTR) that came live earlier this year, and how this affects study start-up.

Is Real-World Data The Real Deal?

Explore how real-world data, and administrative claims data specifically, is being evaluated to support activities in the clinical development space.

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