Phase III-IV

When Every Day Counts

When Every Day Counts

Content provided by Saama

Case Study

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

Using Define-XML to build more efficient studies

Using Define-XML to build more efficient studies

Content provided by Formedix

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 and variables, what terminology is used etc.

Why should you use clinical trial technology?

Why should you use clinical trial technology?

Content provided by Formedix

White Paper

New, innovative clinical trial technology is helping to revolutionize the research landscape. COVID-19 demonstrated that clinical trials can be run much more efficiently and faster than the industry previously imagined

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

Case Study

A growing contract development manufacturing organization (CDMO) was challenged with the need to quickly expand their process liquid and buffer preparation capacity in order to meet the demand for one of their client’s recently approved therapeutic

Unlock potential in buffer preparation

Unlock potential in buffer preparation

Content provided by Thermo Fisher Scientific - Process Liquid Preparation Services

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

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 with this process can be challenging. Beyond procurement challenges, raw materials need to...

Automated metadata management in clinical trials

Automated metadata management in clinical trials

Content provided by Formedix

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 clinical trials, the benefits of automating metadata management, and how to implement standardization...

Validate clinical study data with Formedix CORE

Validate clinical study data with Formedix CORE

Content provided by Formedix

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 Engine (CORE). In this blog, we look at CORE projective objectives, benefits and how Formedix CORE...

SDTM supplemental qualifiers explained

SDTM supplemental qualifiers explained

Content provided by Formedix

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. In this blog, we'll take a detailed look at supplemental qualifiers, with examples.

CNS Drug Development―One Partner From Discovery to Market

CNS Drug Development―One Partner From Discovery to Market

Content provided by Altasciences

White Paper

As a leading partner in central nervous system (CNS) drug development, Altasciences’ in-house preclinical, clinical, bioanalytical, and manufacturing teams have decades of experience formulating, testing, and manufacturing pharmaceutical products that...

Drug Solubility and the Need for Speed

Drug Solubility and the Need for Speed

Content provided by Lonza Small Molecules

White Paper

A growing number of new chemical entities are highly insoluble, leading to problems with bioavailability. Drug manufacturers therefore have to find ways of improving solubility if the product is to succeed. This also has to be done as quickly and...

Are You Prepared to Meet the New FDA Guidelines?

Are You Prepared to Meet the New FDA Guidelines?

Content provided by Elligo Health Research®

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 from underrepresented racial and ethnic populations, specifically Black or African American,...

ODM and CDASH in CRF design

ODM and CDASH in CRF design

Content provided by Formedix

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 in it? In the post, Formedix explains how the ODM can be used as a standard way to define forms,...

4 Warning Signs Your Research Site Is in Trouble

4 Warning Signs Your Research Site Is in Trouble

Content provided by Elligo Health Research®

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 to learn the four warning signs you should keep an eye out for, as they often spell operational and...

2023 State of Clinical Trial Technology Report

2023 State of Clinical Trial Technology Report

Content provided by Florence Healthcare

Insight Guide

Discover the trends shaping clinical trial technology in 2023, from Site Enablement to eISFs, integrations, and site-sponsor collaboration. This report includes insights from 450 sponsors, CROs, and sites, who shared what technology they’re investing in,...

Standardizing data with NCI controlled terminology

Standardizing data with NCI controlled terminology

Content provided by Formedix

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 and ADaM standardize the structures to use when collecting and submitting data, but what about the...

How a Clinical MDR Helps with Data Quality

How a Clinical MDR Helps with Data Quality

Content provided by Formedix

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 get compliant clinical studies submitted faster to regulatory bodies.

Optimizing Adherence in DCTs

Optimizing Adherence in DCTs

Content provided by PPD - Decentralized Clinical Trials

White Paper

Prioritizing greater patient-centricity and creating an opportunity to reach unprecedented patient groups, decentralized and hybrid clinical trials are becoming more widely adopted.

PPD is Supporting Complex EU DCTs

PPD is Supporting Complex EU DCTs

Content provided by PPD - Decentralized Clinical Trials

White Paper

PPD supports European DCTs and clinical trial sponsors with a holistic and comprehensive approach

What should a clinical metadata repository do?

What should a clinical metadata repository do?

Content provided by Formedix

White Paper

Choosing a clinical metadata repository (MDR) software can be a tough task as the capabilities and features of your chosen MDR could make or break your clinical trials. This article explores the features that a clinical MDR software should have.

Helping Trial Sites Overcome Prevailing DCT Challenges

Helping Trial Sites Overcome Prevailing DCT Challenges

Content provided by PPD - Decentralized Clinical Trials

White Paper

As a CRO, PPD (part of Thermo Fisher) can help guide the future of clinical research. Its depth of experience with decentralized clinical trials (DCTs) — all over the world and of many design types — enables PPD to provide insight and feedback-based...

Using SDTM, ADaM, and SEND

Using SDTM, ADaM, and SEND

Content provided by Formedix

White Paper

This article gives an overview of SDTM, ADaM, SEND and ARM, and discusses how these CDISC standards fit in with the wider clinical trial process, and how companies in the pharmaceutical industry can get maximum benefit from them.

How to design an effective CRF

How to design an effective CRF

Content provided by Formedix

White Paper

CRFs and eCRFs are used for gathering patient data during clinical trials. They play a crucial role in helping to assess the safety and efficacy of clinical products.

Because When It's On the Line... Capability Matters.

Because When It's On the Line... Capability Matters.

Content provided by Baxter BioPharma Solutions

Product Brochure

Baxter’s BioPharma Solutions business supports leading pharmaceutical companies in meeting their commercialization objectives by providing scientific expertise, sterile manufacturing solutions, parenteral delivery systems and customized support services...

dPCR Case Study

dPCR Case Study

Content provided by CellCarta

Case Study

Streamline your adoptive cell therapy program with digital PCR. Our team has a unique expertise in digital and quantitative PCR to support you in ensuring your adoptive cell therapy (ACT) meets safety regulations relating to VCN and RCL/RCR levels, even...

Is Your Ancillary Supply Chain Supporting Trial Success?

Is Your Ancillary Supply Chain Supporting Trial Success?

Content provided by Ancillare

White Paper

As the effects of the pandemic reverberate through global supply chains, Sponsors still face many hurdles in sourcing and managing ancillary supplies for clinical trials. Interruptions and delays that once felt like temporary inconveniences are now...

How clinical trial software can optimize trials

How clinical trial software can optimize trials

Content provided by Formedix

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. They need to be able to see and manage their clinical trials effectively so they can improve...

Governing and Maintaining Clinical Data Standards

Governing and Maintaining Clinical Data Standards

Content provided by Veeva

White Paper

Investing in data standards plays a huge role in improving the quality of clinical studies. But often, people don’t use the standards correctly, there are too many variations, or the standards keep changing.

What the Best Clinical Study Build Pros Do

What the Best Clinical Study Build Pros Do

Content provided by Formedix

White Paper

Getting your clinical study designed and built ready for data collection takes A LOT of work and expertise… you've got to do all your CRF designs; keep up with protocol changes; add the annotations; make sure everything aligns with CDISC standards.

The ryze-elluminate integration in clinical trials

The ryze-elluminate integration in clinical trials

Content provided by Formedix

White Paper

The integration between Formedix's ryze CMDR and eClinical's elluminate CDR maximizes automation across the end-to-end clinical trial lifecycle. Read this paper to find out more about the live integration between the two best-in-class softwares, ryze and...

The APAC Advantages

The APAC Advantages

Content provided by Catalent

Insight Guide

Over recent years, the Asia-Pacific (APAC) region has become an emerging market for pharmaceutical and biotech innovation, including clinical studies.

Adapting supply chains to new ways of working

Adapting supply chains to new ways of working

Content provided by World Courier

White Paper

COVID-19 has changed the way we operate. We have adapted our supply chain solutions to meet our clients’ requirements while following World Courier standard procedures. Being flexible is key to develop contingency plans but selecting the right option...

What are the building blocks of DCTs?

What are the building blocks of DCTs?

Content provided by Medable

White Paper

How to create a seamless experience across eConsent, eCOA and more. Over the past year, tremendous progress was made toward digitizing and decentralizing the patient and site experience. While the industry introduced individual point solutions to...

Introduction to eLAS®

Introduction to eLAS®

Content provided by Clinical Ink

Product Brochure

Clinical Ink has developed a unique offering — the electronic Lupus Assessment Suite (eLAS®) to address fundamental challenges impacting systemic lupus erythematosus (SLE) studies and the integrity of the study endpoints.

Clinical Trials 2.0: A Fresh Approach to Systems and Data

Clinical Trials 2.0: A Fresh Approach to Systems and Data

Content provided by Cmed

White Paper

This white paper explores the value of taking a fresh approach to clinical data management, its associated systems and ultimately the processes and roles that surround them. With the right technologies in place, companies can re-invent the traditional...

A Winning End-to-End Solution for Oncology Studies

A Winning End-to-End Solution for Oncology Studies

Content provided by Clinical Ink

White Paper

Oncology clinical trials present a unique set of challenges for patients, study sites, and study sponsors. Using electronic patient reported outcomes (ePRO) in conjunction with agile methodology enables nimble, efficient clinical data management...

Lessons Learned: Clinical Trials During a Pandemic

Lessons Learned: Clinical Trials During a Pandemic

Content provided by PCM TRIALS

White Paper

In a recent survey of clinical trial professionals (including pharmaceutical sponsors, CROs, site representatives and vendors), respondents reported that one of their most significant concerns was clinical trial patient recruitment and retention. This...

Global Pediatric Drug Development Collaboration: Part One

Global Pediatric Drug Development Collaboration: Part One

Content provided by PRA Health Sciences

White Paper

The pharmaceutical industry is unlike any other industry in that the products manufactured can dramatically improve, and even save, lives. This is especially the case when it comes to children. Although pediatric patients comprise a smaller population of...

Global Pediatric Drug Development Collaboration: Part Two

Global Pediatric Drug Development Collaboration: Part Two

Content provided by PRA Health Sciences

White Paper

70% of medicines given to children have never been studied in pediatric populations. Children who need treatments represent a relatively small population. This alone presents unique challenges for pediatric drug development. Since the 1990s, authorities...

Outsourcing Analytical Testing for Biologics - A CRO's Perspective

Outsourcing Analytical Testing for Biologics - A CRO's Perspective

Content provided by Frontage Laboratories

White Paper

Biologics are complex large molecules derived from living organisms or manufactured from cells, and they have inherent structural heterogeneity. Indeed, proteins, given their chemistry, are the “most structurally complex and functionally sophisticated...