A top-10 pharma sponsor's aggressive Phase III cardiovascular timeline, modeled head-to-head against real-world data — surfacing a diversified country mix that cut 118 days to LPI and raised success odds from 85% to 94%.

The webinar explores the key limitations and downstream impacts of an oversimplified enrollment forecasting and tracking model. In conversation with leaders from CSL Behring and Merck, we share best practices on how to properly use benchmark studies, model different scenarios based on inputs (not outcomes), diagnose enrollment delays, and choose the right combination of interventions to get enrollment back on track.

Sites complete every module and sign every attestation, and still end up learning your protocol through trial and error on real patients. This whitepaper breaks down why legacy LMS and CRO-delivered training can't close that gap, what ICH E6(R3) now expects instead, and what a sponsor-owned approach looks like when it actually works. 

Most enrollment plans are built once, hold a single number, and stay untouched until a milestone forces a reckoning. This nine-question self-assessment shows where your forecasting process actually sits — reactive, responsive, predictive, or optimized — and what closes the gap.

Speeding therapies to market requires more than faster development; it demands a smarter regulatory strategy. This eBook explores how life sciences organizations are leveraging expedited regulatory pathways, reliance procedures and global regulatory collaborations to accelerate approvals while maintaining regulatory rigor. Learn how FDA, EMA and PMDA accelerated pathways are being used in practice, how reliance models and consortia initiatives can support global submissions, and why regulatory intelligence is critical for navigating evolving requirements and bringing innovative therapies to patients faster.

Fix formatting issues in Word documents and reduce rework across your team.

OnStyle combines structured authoring, configurable standards, and automated validation.

Fix formatting issues in Word documents and reduce rework across your team.

OnStyle combines structured authoring, configurable standards, and automated validation.

Fix formatting issues in Word documents and reduce rework across your team.

OnStyle combines structured authoring, configurable standards, and automated validation.

Inconsistent formatting, hidden errors, and manual checks cost time, create rework, and increase risk.
OnStyle automatically identifies and fixes formatting issues in Word, while enforcing your standards in the background.

Less rework. Faster approvals. More compliant documents.

All too often documents are formatted inconsistently and contain errors. Your team follows standards—but enforcing them costs time, rework, and approvals... Until now. Meet OnStyle. OnStyle automatically identifies and corrects issues in Word documents. And, when creating new documents, it helps by applying standard styles and formatting rules... Reduce risks, speed up your  process, and create compliant documents. Try OnStyle for free and claim your 26% discount while available.

Most pharma organizations continue to face persistent challenges in shortening submission timelines.

Read this whitepaper to discover how an AI-first, structured content authoring solution can help you create data-centric documentation:

• Slash authoring times, create first-time-right drafts faster with GenAI
• Enable efficient document lifecycle management with automated content reuse
• Keep track of the regulatory submissions process by automating complex data analysis
• Accelerate global submissions with faster translation and localization
• Achieve predictive compliance by forecasting regulatory changes that need to be implemented
• Deploy a single solution for the creation, management and publication of  dossiers
• Innovate with confidence and win the race

The decentralised procedure (DCP) is the European Union-wide procedure for authorising medicines in more than one European Union Member State in parallel. It can be used for medicines that do not need to be authorised via the centralised procedure and have not already been authorised in any Member State. The procedure falls under the Directive 2004/27/EC.

In the decentralised procedure, the applicant chooses one country as the reference Member State when making its application for marketing authorisation. The marketing authorisation in all chosen Member States is received simultaneously, enabling simultaneous marketing of the medicine and reducing the administrative and regulatory burden.

Access a comprehensive overview of our company through our Corporate Presentation. This document provides detailed insights into our mission, vision, and values, along with an overview of our core business areas, growth strategies, recent achievements, and future outlook.

Designed to offer a clear and concise perspective of who we are, what we do, and how we create value for our clients, partners, this presentation serves as an essential resource for understanding our organization.

Download it now to learn more about our value proposition, our team, and the opportunities we are driving.

A small biotech needed an informed consent form (ICF) for an IND submission, with limited lead time following agency feedback. The challenge was compounded by a lack of prior materials and an untested template.

Synterex’s Solution:
AgileWriter™ was pretrained using draft sources and updated incrementally as new protocol information became available. The model’s output was so robust it was also leveraged to produce a pregnant partner ICF for the same study.

A medium-sized biotech faced a tight deadline: a comprehensive Clinical Study Report (CSR) shell and first draft were needed in just two weeks, compared to the industry norm of six or more. The project was further complicated by complex oncology study design and data in less-than-ideal formats.

Synterex’s Solution:
Leveraging AgileWriter™, Synterex trained an AI model in real time, mapping planned content to a CSR template and SDTM datasets. As new information arrived, the model was incrementally refined, with a medical writer overseeing the process to ensure quality and compliance.

Digital tools in pharmacovigilance are increasingly valued for their transformative potential. Integrating these tools requires a strategic approach merging technological capability with regulatory compliance.

Evernorth® Health Services, collaborating with a contract research organization (CRO), performed direct-to-patient outreach to recruit patients for a pediatric vaccine trial to support a pharmaceutical sponsor. An incredible 700,000+ eligible patients within the age range were initially identified. After applying advanced analytics to narrow down to those most likely to qualify, households with multiple children were consolidated to maximize outreach efficacy.

Discover how a pharmaceutical company leveraged advanced analytics to streamline site selection for a Phase III oncology trial, ensuring efficient patient recruitment and high-quality data collection. Learn how integrating patient demographics, investigator profiles, and social determinants of health can enhance trial outcomes and accelerate drug development.

Discover groundbreaking insights into migraine prevalence, treatment variations, and healthcare provider dynamics with the PurpleLab Migraine Study. This comprehensive whitepaper leverages real-world data to illuminate the complexities of migraine management, offering valuable intelligence for healthcare providers and life sciences companies.

Life sciences companies are operating in a new world, one where new treatments are being developed at breakneck speed, which holds unprecedented promise for patients. However, this new world is also one that requires the use of real world data (RWD) to empower marketing teams to effectively engage with various stakeholders – and ultimately lead healthcare providers to prescribe innovative drugs to the patients who will truly benefit from these treatment therapies.

Analyzing real-world data (RWD) in pharmaceutical marketing has the power to unearth hidden trends and insights into the overall prescription landscape. However, accessing and compiling this data tends to be a resource-intensive process. This case study explores how PurpleLab’s Prescription Measurement Report empowered the marketing agency Deerfield to harness RWD insights effectively.

The pharmaceutical industry is evolving rapidly, but inefficient research workflows can slow innovation. With scientific literature growing exponentially and regulatory compliance becoming more demanding, AI is emerging as a transformative tool. 

This white paper explores how AI-driven solutions can streamline literature reviews, accelerate drug discovery, and enhance compliance, ultimately reducing time-to-market for critical breakthroughs. Learn how AI can automate tedious processes, improve data management, and provide real-time insights—allowing researchers to focus on what truly matters: advancing medicine. Dive in and discover the future of pharmaceutical research!

Introducing Literature Review by ReadCube

Systematic Literature Reviews (SLRs) help researchers and organizations navigate the growing sea of academic knowledge. Yet, traditional SLRs are slow, costly, and error-prone due to fragmented workflows.

What if you could transform your SLR process?

In The Future of Systematic Literature Reviews white paper, ReadCube introduces an AI-driven solution that streamlines workflows, reducing costs and improving accuracy. Discover the challenges of traditional reviews, the role of AI and automation, and how an all-in-one platform saves time and enhances efficiency.

Don't rely on outdated methods—download the white paper now!

Moderna, a leading mRNA technology company, saw unprecedented growth during the COVID-19 pandemic. Before this, its Medical Affairs teams aligned Research and Commercial narratives via a scientific communications platform (SCP) set annually with little change.

During the pandemic, daily data on the virus, its evolution, vulnerable populations, efficacy, durability, and real-world evidence (RWE) surged, overwhelming existing tools.

This case study explores how Moderna Medical Affairs used ReadCube’s platform as a centralized repository for efficient content management and integration, enhancing research accuracy, data efficiency, and collaboration.

Prior to the FD&C Act, pharmaceutical companies were not required to provide proof of drug safety or a disclosure of all active ingredients. Since then, all new drugs undergo an intensive review process by the Food and Drug Administration (FDA), and ever-evolving guidance and regulations ensure that both new drugs and those with updated characteristics, such as dosing, delivery, and expanded indications, are safe and effective for the intended populations. A gap remains, however, for drug investigations including and targeted for children of varying ages.

Download and read now for more insights!

Innovative development of human drugs, biologics, and medical devices (medical products) and their quick advancement through the United States Food and Drug Administration (FDA) approval pipeline is necessary to improve the lives of patients. It is also imperative for sponsors to consider diversity when enrolling study participants throughout the clinical development pipeline to adequately represent the population of patients who have a disease or condition.

Download and read now for more insights!