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Streamlining early phase drug development with continuous flow technologies

Lonza’s innovative continuous flow technology and mini-monoplant approach are transforming early-phase drug development. How can they accelerate timelines and reduce costs?

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Achieving data integrity: Best practices for secure and reliable data management

In today's regulatory landscape, ensuring data integrity is crucial for compliance and process visibility. How can organizations enhance accuracy, consistency, and reliability?

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AI transforms route scouting for faster drug synthesis

Applying AI-enabled route scouting services allows drug developers to avoid pitfalls that can typically occur in drug synthesis, speeding up drug substance IND.

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Decentralized clinical trials: The trends, the market and the future

Decentralized clinical trials can help improve the process of clinical trials for patients since factors like COVID disrupted the industry.

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Insights into creating an inhaler product through jet milling

Respiratory diseases require new treatments. Drug developers in the space can look to jet milling – a crucial process to create many dry powder inhaler products.

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Control Towers in clinical trials: Harnessing logistics best practice to address pain points in the clinical trials market

There are many logistical obstacles faced by pharmaceutical companies. A Control Tower can provide quality controls built into processes from the outset.

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Reducing the complexity of drug development through integrated services

Biotech companies face risks in drug development. Partnering with a CDMO that provides an integrated offering can reduce the potential for delays and greater expenses.

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Leveraging global logistics expertise for improved patient outcomes

Logistics is so much more than the movement of goods, it can enhance patient retention, improve patient diversity, reduce costs get products to market faster.

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The opportunity to de-risk drug development through PBPK

No company wants to progress a molecule through to the clinic only to suffer a bad readout. PBPK modeling services allow companies to predict what absorption challenges may arise in trials, and plan ways to mitigate them.

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Hybrid Freezing & Thawing: An all-in-one solution

When drug substances are frozen, the effect of cryoconcentration occurs, resulting in a loss of product quality. Hybrid plate-based freeze and thaw platforms prevent the aggregation of biologics in both, single-use bags and bottles.

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Achieving patient centricity through multiparticulate technology

The push towards greater patient centricity sees the need to create more flexible formulation options to patients, which is where multiparticulate technology can offer solutions in drug development.

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Akihiro Kadokura of AGC Pharma Chemicals: the CDMO's industry edge and sustainability commitments

Akihiro Kadokura, CEO of AGC Pharma Chemicals, shares his thoughts on the current challenges for the pharmaceutical industry and AGC's commitment to sustainability.

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Modularization of manufacturing for increased process flexibility

Process flexibility allows CMOs to adapt to the needs of the pharmaceutical industry. It will be inevitable to resort to modular systems in fluid management.

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How to expedite your clinical trial reporting: The pivotal role of AI

A premier resource of AI for life sciences, pioneers can save up to 30% of time generating crucial reports for regulatory submission.

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Envigo is addressing the need for models that mimic the long-term effects of COVID-19

Envigo is leading the charge to advance therapeutic research for long COVID with a new humanized ACE2 mouse that closely mimics human responses to SARS-CoV-2 infection.

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Helping Sponsors Navigate Complex Ancillary Supply Sourcing Challenges with Integrated Services

As the clinical trial landscape becomes increasingly complex, the needs of trials sponsors with respect to ancillary clinical suppliers also become more intricate. Many more types of supplies, including medical equipment and diagnostic tests, are needed...

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The Fast & The Flexible: How to Take Control of Your Clinical Data

Challenges abound with typical clinical data review. Here’s how to avoid them so that you can maintain control throughout the process.

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Ensuring Clinicians Obtain the Right Data at the Right Time

Trials can often experience impediments great and small. Here’s how unified analytics platforms can provide real-time data for more accurate, expedient review.

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Scaling up eConsent

The informed consent process is fundamental to every clinical trial. Study participants must be provided with sufficient information to understand the study, its procedures and commitments, the possible treatments they may receive, and any possible risks...

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How Advanced Technologies Ensure Accuracy of Your Clinical Trials

Decentralized/Virtual Clinical trials are being transformed by swiftly emerging technologies. Direct-to-patient models require trial data to be protected and accurate. Not all organizations are equipped to do that. Yourway is.

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Building resilient healthcare supply chains post-pandemic

COVID-19 drastically reconfigured APAC healthcare supply chains in the past year. So what’s next?

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Chronic COVID syndrome: a new study shows the positive effects of using Apportal, a targeted nutritional supplement

An investigation was recently conducted in Italy on around 200 post-Covid patients suffering from persistent fatigue, who were advised to take Apportal for 28 days

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Scaling up for Vaccine Delivery in 2021

The convergence of the seasonal flu and COVID-19 transmissions this winter presents an unprecedented challenge not just for the logistics industry but for people around the world. So how are we preparing to ship billions of vaccines across Asia Pacific?

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Elevating Effective Outcomes with Companion Diagnostics

Companion diagnostics (CDx) is a keystone for pharma to create more precise drug therapies as personalized medicine accelerates. Here’s why a CDx central laboratory partner is necessary.

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Milling for Tablet Making

Preparing ingredients for tablet making is far more critical than most give it credit. The main objective in milling is to reduce particle size to within a specific range while minimizing the generation of fines (dusty particles).

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Handling complexity in GI trials ⁠— a purpose-built eCOA/ePRO solution

The accelerating complexity of gastroenterology protocols has exceeded the capacity of most electronic clinical outcome assessments (eCOAs) to adapt.

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Challenges Arise as the Need for Pediatric Research Increases

With pediatric clinical trials increasing with the RACE Act, we need to consider the hurdles that will be faced when it comes to enrollment, costs, and trial design.

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Challenges in choosing the correct HPLC/LC-MS column for biologics characterization?

Industry pipelines and portfolios have changed significantly, in recent years, with the small molecules that used to dominate increasingly giving way to biologics.

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Accelerating Database Lock: Adaptive Design & Remote Monitoring

CASE STUDY: A pharmaceutical company conducting a Phase III study of an investigational ointment required an eSource solution that could support remote monitoring, video uploads, and image capture and provide push-button randomization.

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Protecting Clinical Trials in Wake of COVID-19

In an unprecedented time of worldwide disruption, Yourway helps you navigate the critical supply chain journey for successful clinical trial development, execution, and conclusion.

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Managing Research Risks During an Emerging Infectious Diseases Event: A Coronavirus Case Study

The news is filled with stories about the novel 2019 coronavirus (2019-nCov or SARS-CoV-2). Emerging infectious diseases are part of the reality of a globalized civilization

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Investment Recovery: Partnering for Surplus Asset Management

Companies that want to recover their investment in equipment assets are better positioned if they have a comprehensive plan in place before the surplus is evident

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SUCCEED WITH BYOD FOR ePRO IN ANY PHASE OF CLINICAL RESEARCH

As more and more people own smart phones, bring your own device (BYOD) patient data collection often makes sense. What are the risks and opportunities presented by such a strategy?

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How personalized medicines are disrupting the supply chain

Sponsors for a Phase 2 clinical trial needed an expensive, time-sensitive therapy transported to investigator sites at -80º C. Further, when reaching out to cryogenic shipper rental companies, the sponsor found they often transport regionally and do not...

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Datwyler's Starter Pack - A Single Source Solution for Drug Discovery Through Drug Delivery

Datwyler Sealing Solutions is a leading industrial supplier and a key player in the global healthcare industry. The Swiss-based company offers state-of-the-art solutions for parenteral packaging and medical devices, built on more than 100 years of experience....

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Tracking your Project from Packaging Line to Patient

Supporting the delivery of clinical trial materials requires more than a logistics service provider. Clinical trials are growing in number and complexity. More trials are dispersed over many locations in different countries of the world with varying regulations...

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Improve the efficiency of your impurity testing

Improve the efficiency of your impurity testing with ready-to-use pharmaceutical impurity solutions manufactured as ISO approved Certified Reference Materials (CRMs)

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Marken Advances Critical Supply Chain

Cell and gene therapies are the next-generation healthcare protocols, and the human trials into their efficacies are rising. An advanced supply chain solutions provider is the key to success.

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Who Needs to Comply With the Revised Common Rule and What Does It Mean for Informed Consent Forms?

Most requirements for the revised Common Rule are in effect. This article serves as a guide for researchers who are still unsure if they need to comply or what that means when it comes to informed consent form (ICF) requirements.

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Mastering clinical drug distribution in an era of advanced therapies and global trials

The composition of clinical trial pipelines is changing quickly as the rise of advanced therapies adds another layer to the multi-decade shift from small molecules to biologics. This change is fueling once-unimaginable advances in the treatment of cancers,...

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Mining Real-World Data with Cutting-Edge Analytical Tools

In 1848, the most famous Gold Rush in American history began at Sutter's Mill near present-day Coloma, California, shaping the US economic map forever. In those days, there were no scientific tools to guide prospectors in their search. Sites of previous...

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Introducing Roquette’s Pearlitol SW-F (wheat-free) DC mannitol for nutraceutical dosage forms

Providing on-the-go, health-conscious consumers with fast-acting, easy-to-take and affordable healthcare products is a top priority for OTC drug and nutraceutical manufacturers and marketers.

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How companies are realizing the potential of virtual and hybrid clinical trials

Virtual and hybrid clinical trials have arrived. Having learnt from pilot projects, pharma companies are systematically incorporating patient-centric services into trials, resulting in a significant minority of today’s studies featuring virtual elements....

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New Track & Trace User Academy: Reducing the ramp up time by observing and learning T&T in the wild

Major markets are mandating the implementation of serialization. The new Track & Trace User Academy brings personnel up to speed on using equipment and processes correctly.

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Collaborating with Lilly Spain to increase productivity through planned professional maintenance – Part 1

“The whole system will be very useful, it is very complete and more intuitive than any other system we have seen,.” – Pablo Poza, Maintenance Coordinator at Lilly Spain

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Risk mitigation: mission critical

Pharmaceutical manufacturers need to understand and mitigate the risk in supply chain logistics. World Courier explore five rising trends impacting security of a product in transport.

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SEDDS for oral peptide delivery: Gattefossé insight

Peptide therapeutics are on the rise due to their high potency, specific mode of action and safety. Currently, more than 60 peptides are available on the market. About 140 are in clinical trials and 500 are in preclinical development (Fosgerau and Hoffmann,...

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The move from cold-chain to temperature-controlled shipping

World Courier shares an overview of the key issues and new developments in temperature-controlled shipping. 

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Extractables and leachables analysis of pharmaceutical products

A crucial undertaking when releasing pharmaceutical products for the market, is to determine the purity of the final product, necessitating the need to determine its impurity profile. Traditionally, this was concerned only with those impurities arising...

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Cleaning Validation - What do you need to consider to ensure a successful outcome?

Cross contamination must be avoided in the pharmaceutical industry at all costs. Successful cleaning validation ensures that patients are not put at risk due to cross contamination. The process can be divided into a number of sections each of which must...