Phase I-II

69 Results

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...

Internal Standard (IS) Variation Case Studies: Emerging from Three Common IS Challenges

Content provided by WuXi AppTec | 01-Nov-2023 | Application Note

The use of internal standards (IS) is essential for developing and applying liquid chromatography-tandem mass spectrometric (LC-MS/MS) quantitative bioanalytical...

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?

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...

Clinical Data Automation: The Time is Now

Content provided by Saama | 25-Oct-2023 | White Paper

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Three ways to leverage AI in Clinical trials right now

Content provided by Saama | 25-Oct-2023 | White Paper

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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

ICH M10 Guidance: Harmonization and Modification to Bioanalytical Method Variation

Content provided by WuXi AppTec | 20-Oct-2023 | Application Note

Global regulatory standards govern bioanalytical method development, validation and the subsequent assays. When those standards are updated, industry stakeholders...

Why should you use clinical trial technology?

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

New, innovative clinical trial technology is helping to revolutionize the research landscape.

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...

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...

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

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

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....

CNS Drug Development―One Partner From Discovery to Market

Content provided by Altasciences | 02-May-2023 | White Paper

As a leading partner in central nervous system (CNS) drug development, Altasciences’ in-house preclinical, clinical, bioanalytical, and manufacturing teams...

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....

A Guide Through the API Drug Development Pipeline

Content provided by Lonza Small Molecules | 04-Apr-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...

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?

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

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...

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

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...

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...

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...

Optimizing Adherence in DCTs

Content provided by PPD - Decentralized Clinical Trials | 12-Jan-2023 | White Paper

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

PPD is Supporting Complex EU DCTs

Content provided by PPD - Decentralized Clinical Trials | 05-Jan-2023 | White Paper

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

What should a clinical metadata repository do?

Content provided by Formedix | 14-Dec-2022 | 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...

Helping Trial Sites Overcome Prevailing DCT Challenges

Content provided by PPD - Decentralized Clinical Trials | 13-Dec-2022 | 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)...

Using SDTM, ADaM, and SEND

Content provided by Formedix | 09-Nov-2022 | 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...

How to design an effective CRF

Content provided by Formedix | 10-Oct-2022 | 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...

The Complexities of Ophthalmic Drug Development

Content provided by Altasciences | 04-Oct-2022 | White Paper

Ophthalmic drug development comes with a unique set of challenges that can be mitigated by working with an end-to-end solution provider with regulatory...

Automating clinical trials: Why it's essential

Content provided by Formedix | 05-Sep-2022 | White Paper

Automation is used to improve the accuracy of results in the clinical trial process from study setup through to submission.

dPCR Case Study

Content provided by CellCarta | 08-Aug-2022 | 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...

Planning Your First-In-Human Trial

Content provided by Altasciences | 15-Jul-2022 | White Paper

A first-in-human (FIH) clinical trial is a significant milestone in the development of a potential new drug. A successfully conducted FIH trial provides...

Is Your Ancillary Supply Chain Supporting Trial Success?

Content provided by Ancillare | 06-Jul-2022 | 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...

Pediatric Formulations: Identifying & Addressing Children’s Needs

Content provided by Piramal Pharma Solutions | 30-Jun-2022 | White Paper

Developing formulations for pediatric patients poses unique challenges. The specific needs of children, which vary by age, mean the task goes beyond scaling...

Strategic Approach to Immunogenicity Assessment

Content provided by Altasciences | 17-May-2022 | White Paper

In this issue of The Altascientist we provide a detailed overview on the different goals and challenges that are presented by the validation of immunogenicity...

Governing and Maintaining Clinical Data Standards

Content provided by Veeva | 10-May-2022 | 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...

What the Best Clinical Study Build Pros Do

Content provided by Formedix | 09-May-2022 | 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;...

Home Health in Clinical Trials — A Better Way to Meet Patients’ Needs

Content provided by Firma Clinical Research | 13-Apr-2022 | Infographic

Meeting patient needs today is complicated. But there is one thing that can minimize their burden, improve retention, and maximize protocol compliance....

The ryze-elluminate integration in clinical trials

Content provided by Formedix | 28-Mar-2022 | White Paper

The integration between Formedix's ryze CMDR and eClinical's elluminate CDR maximizes automation across the end-to-end clinical trial lifecycle....

Clear Guidelines for IND/CTA

Content provided by Altasciences | 24-Feb-2022 | White Paper

There are many challenges associated with early drug discovery and development. Advancing your best candidate for regulatory submissions requires a careful...

The APAC Advantages

Content provided by Catalent | 18-Jan-2022 | Insight Guide

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

Planning Your Preclinical Assessment

Content provided by Altasciences | 17-Jan-2022 | White Paper

There are many challenges associated with early drug discovery and development. Advancing your best candidate for regulatory submissions requires a careful...

Automating clinical trials for success

Content provided by Formedix | 06-Oct-2021 | White Paper

This article gives gives a brief overview of why automation is absolutely essential for clinical trial success.

Adapting supply chains to new ways of working

Content provided by World Courier | 15-Jul-2021 | 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...

Empowering Clinical Trial Sponsors with Analytics

Content provided by PerkinElmer | 14-Jul-2021 | White Paper

Is your Clinical Data Review creating problems or solving them? Take Control of Your Data. PerkinElmer Informatics Clinical Solutions, powered by Tibco...

What are the building blocks of DCTs?

Content provided by Medable | 26-Apr-2021 | White Paper

How to create a seamless experience across eConsent, eCOA and more.

Over the past year, tremendous progress was made toward digitizing and...

Introduction to eLAS®

Content provided by Clinical Ink | 08-Mar-2021 | Product Brochure

Clinical Ink has developed a unique offering — the electronic Lupus Assessment Suite (eLAS®) to address fundamental challenges impacting systemic lupus...

Clinical Trials 2.0: A Fresh Approach to Systems and Data

Content provided by Cmed | 01-Mar-2021 | 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...

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