Technical Papers

729 Results

More Data, More Insights, More Progress

More Data, More Insights, More Progress

Content provided by Saama | 04-Mar-2024 | Case Study

The sponsor’s clinical development team needed a flexible solution to quickly visualize patient and site data in a single location

Ultra Low Temperature Packaging solutions

Ultra Low Temperature Packaging solutions

Content provided by Almac Group | 12-Feb-2024 | Case Study

Advanced Therapy Medicinal Products (ATMPs) offer ground-breaking opportunities for treating injuries and disease, in particular for cases of severe, untreatable...

Using Define-XML to build more efficient studies

Using Define-XML to build more efficient studies

Content provided by Formedix | 14-Nov-2023 | White Paper

It is commonly thought that Define-XML is simply a dataset descriptor: a way to document what datasets look like, including the names and labels of datasets...

Increasing the Bioavailability of Oncology Drugs

Increasing the Bioavailability of Oncology Drugs

Content provided by Lonza Small Molecules | 13-Nov-2023 | White Paper

Oral tyrosine kinase inhibitors (TKIs) are a class of cancer drugs that can be highly susceptible to issues with solubility in the gastrointestinal tract

Efficient Freezing & Storage of Biopharmaceuticals

Efficient Freezing & Storage of Biopharmaceuticals

Content provided by Single Use Support | 06-Nov-2023 | White Paper

Various options exist for freezing biopharmaceutical bulk material, but selecting the most effective and efficient approach for each cold chain can be...

Overcoming rapid growth challenges with process liquid preparation

Overcoming rapid growth challenges with process liquid preparation

Content provided by Thermo Fisher Scientific - Process Liquid Preparation Services | 01-Nov-2023 | Case Study

A growing contract development manufacturing organization (CDMO) was challenged with the need to quickly expand their process liquid and buffer preparation...

Why should you use clinical trial technology?

Why should you use clinical trial technology?

Content provided by Formedix | 01-Nov-2023 | White Paper

New, innovative clinical trial technology is helping to revolutionize the research landscape. COVID-19 demonstrated that clinical trials can be run much...

When Every Day Counts

When Every Day Counts

Content provided by Saama | 25-Oct-2023 | Case Study

While developing a vaccine for COVID-19, a Top 3 pharmaceutical company had an urgent need

Pulmonary Delivery of Orally Inhaled Therapeutics

Pulmonary Delivery of Orally Inhaled Therapeutics

Content provided by Catalent Pharma Solutions | 19-Oct-2023 | Business Advice

New classes and indications of orally inhaled therapeutics are rapidly expanding, with the development pipeline increasingly featuring both large and small...

Addressing Challenges with Clinical In-Use Testing

Addressing Challenges with Clinical In-Use Testing

Content provided by Lonza | 12-Oct-2023 | White Paper

Lonza Drug Product expert Léa Sorret PhD explores Clinical In-Use Testing of Biotherapeutics in this white paper. Léa shares her expertise and describes...

PBPK modeling that saves you time and money

PBPK modeling that saves you time and money

Content provided by Lonza Small Molecules | 09-Oct-2023 | White Paper

Understanding pharmacokinetic behaviors ahead of later-stage development means making informed decisions earlier. This enhanced capability helps your drug...

Manufacturing Drugs with Highly Potent APIs

Manufacturing Drugs with Highly Potent APIs

Content provided by Altasciences | 28-Sep-2023 | White Paper

In this issue of The Altascientist, we examine the critical considerations for the safe and compliant manufacture of drugs with highly potent APIs (HPAPIs),...

Unlock potential in buffer preparation

Unlock potential in buffer preparation

Content provided by Thermo Fisher Scientific - Process Liquid Preparation Services | 18-Sep-2023 | Infographic

Consider how the right partner can help you scale faster, mitigate risks, and optimize resources.

Plan for success with process liquid and buffer preparation

Plan for success with process liquid and buffer preparation

Content provided by Thermo Fisher Scientific - Process Liquid Preparation Services | 14-Aug-2023 | White Paper

Setting the groundwork for successful scale-up is essential for getting a therapeutic to market quickly and efficiently, but navigating the unknowns associated...

Automated metadata management in clinical trials

Automated metadata management in clinical trials

Content provided by Formedix | 01-Aug-2023 | White Paper

When it comes to efficient clinical study build, content is king. Most importantly: metadata content. In this blog, we explore the role of metadata in...

A Guide Through the API Drug Development Pipeline

A Guide Through the API Drug Development Pipeline

Content provided by Lonza Small Molecules | 11-Jul-2023 | Insight Guide

With the complexities associated with API and HPAPI drug development, it’s necessary to lean on the experts. With Q&A sections, insights and articles...

Small Molecule development – getting it right

Small Molecule development – getting it right

Content provided by Lonza Small Molecules | 20-Jun-2023 | Insight Guide

Small Molecule drug development is something more and more ambitious emerging pharmaceutical companies are taking on from end to end. But this path can...

Validate clinical study data with Formedix CORE

Validate clinical study data with Formedix CORE

Content provided by Formedix | 19-Jun-2023 | White Paper

In April 2023 at the CDISC Europe Interchange, we launched Formedix CORE, the first free-to-use, downloadable application encompassing the CDISC Open Rules...

SDTM supplemental qualifiers explained

SDTM supplemental qualifiers explained

Content provided by Formedix | 12-May-2023 | White Paper

What are SDTM supplemental qualifiers? In short, these are variables in non-CDISC datasets that cannot be mapped to a variable that matches the SDTM standard....

How clinical trial software can optimize trials

How clinical trial software can optimize trials

Content provided by Formedix | 17-Apr-2023 | White Paper

Companies often have to conduct multiple clinical trials at the same time, which means they've got to be efficient, and compliant with industry regulations....

4 Warning Signs Your Research Site Is in Trouble

4 Warning Signs Your Research Site Is in Trouble

Content provided by Elligo Health Research® | 13-Apr-2023 | Insight Guide

You want your clinical research practice to be a success for your business and your patients, but how can you tell if it’s in trouble? Read this article...

The Complete Guide to eRegulatory and eSource

The Complete Guide to eRegulatory and eSource

Content provided by Florence Healthcare | 01-Apr-2023 | Insight Guide

Shifting to eRegulatory and eSource workflows is a requirement for clinical trial sites to continue to scale and grow their studies. This guide is designed...

Drug Solubility and the Need for Speed

Drug Solubility and the Need for Speed

Content provided by Lonza Small Molecules | 28-Mar-2023 | White Paper

A growing number of new chemical entities are highly insoluble, leading to problems with bioavailability. Drug manufacturers therefore have to find ways...

Are You Prepared to Meet the New FDA Guidelines?

Are You Prepared to Meet the New FDA Guidelines?

Content provided by Elligo Health Research® | 23-Mar-2023 | Insight Guide

On April 15, 2022, the U.S. Food and Drug Administration issued a new draft guidance to clinical research sponsors on creating a plan to enroll more participants...

ODM and CDASH in CRF design

ODM and CDASH in CRF design

Content provided by Formedix | 10-Mar-2023 | White Paper

The lesser-known Operational Data Model (ODM) standard is often overlooked as it's not required by any regulators. So, why should you be interested...

Designing an Optimal APAC Clinical Supply Chain

Designing an Optimal APAC Clinical Supply Chain

Content provided by Catalent | 08-Mar-2023 | Infographic

With clinical study activity increasing across the Asia-Pacific region, it is important for sponsors—both in APAC and globally—to understand the broader...

How Sponsors Reduce Chaos in Decentralized Trials

How Sponsors Reduce Chaos in Decentralized Trials

Content provided by Florence Healthcare | 08-Mar-2023 | Insight Guide

89% of research sponsors currently use and expect to continue the use of decentralized technologies and methods, according to our state of the industry...

2023 State of Clinical Trial Technology Report

2023 State of Clinical Trial Technology Report

Content provided by Florence Healthcare | 01-Mar-2023 | Insight Guide

Discover the trends shaping clinical trial technology in 2023, from Site Enablement to eISFs, integrations, and site-sponsor collaboration. This report...

Life Cycle Extension: A Molecule’s Full Potential

Life Cycle Extension: A Molecule’s Full Potential

Content provided by Piramal Pharma Solutions | 16-Feb-2023 | White Paper

Winning approval for a new molecular entity is just a staging post on the journey of a drug. To maximize the benefits of a therapy, drugmakers need to...

Standardizing data with NCI controlled terminology

Standardizing data with NCI controlled terminology

Content provided by Formedix | 13-Feb-2023 | White Paper

The use of consistent terminology within and between studies is critical to enabling an efficient trial process. CDISC standards such as CDASH, SDTM, SEND...

Enhance your cGMP chemical supply chain

Enhance your cGMP chemical supply chain

Content provided by Thermo Fisher Scientific – Production Chemicals and Services | 09-Feb-2023 | White Paper

Supply chain issues have real, quantifiable impacts on biomanufacturers. However, the right support can make a cGMP supply chain operate seamlessly. Thermo...

How a Clinical MDR Helps with Data Quality

How a Clinical MDR Helps with Data Quality

Content provided by Formedix | 16-Jan-2023 | White Paper

This article covers the many ways a clinical metadata repository helps with data quality in the clinical trial process, and how it ultimately helps to...

Understanding the hidden value of quality

Understanding the hidden value of quality

Content provided by Thermo Fisher Scientific – Production Chemicals and Services | 16-Jan-2023 | White Paper

The raw material supply is too vital to leave to chance, and quality-related supply chain activities are cornerstones to your success.