Technical Papers

702 Results

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....

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 | 25-Apr-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...

cGMP Assurance of Supply Services Case Study

cGMP Assurance of Supply Services Case Study

Content provided by Thermo Fisher Scientific - Process Liquid Preparation Services | 18-Apr-2023 | Case Study

Having the right raw materials available for production when they’re needed is imperative, as delays can negatively impact production schedules. Manufacturers...

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...

A Guide Through the API Drug Development Pipeline.

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...

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...

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.

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...

Optimizing Adherence in DCTs

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

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?

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

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

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...

INDENA ALWAYS AT THE FOREFRONT FOR CDMO SERVICES

INDENA ALWAYS AT THE FOREFRONT FOR CDMO SERVICES

Content provided by Indena | 25-Oct-2022 | White Paper

Indena is well known in the space of naturally derived molecules, with a know-how developed over its one hundred year history. At the same time, the company...

How to design an effective CRF

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

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...

dPCR Case Study

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

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...

Consideration and Options for Prefilled Syringes

Consideration and Options for Prefilled Syringes

Content provided by Baxter BioPharma Solutions | 13-Jul-2022 | White Paper

Convenience, product differentiation, and less waste are great reasons for developing a product in a prefilled syringe. Baxter’s whitepaper describes the...

Seasonal Vaccine Manufacturing

Seasonal Vaccine Manufacturing

Content provided by Baxter BioPharma Solutions | 13-Jul-2022 | White Paper

The production of seasonal vaccines, such as those for influenza, presents unique challenges to manufacturers due to the necessary time constraints resulting...

Multiple Sclerosis Analytical Report

Multiple Sclerosis Analytical Report

Content provided by PatSnap | 15-Jun-2022 | White Paper

More than 2.3 million people are living with MS worldwide. Although there is no cure, new research and innovative treatments are continuously emerging....

Implementing Patient Co-Creation in Clinical Trials

Implementing Patient Co-Creation in Clinical Trials

Content provided by THREAD | 14-Jun-2022 | Insight Guide

Patient co-creation in clinical research means a shift from thinking about the patient to thinking with the patient. This means that patients are giving...

Flexible Filling Solution for CMOs

Flexible Filling Solution for CMOs

Content provided by Single Use Support GmBH | 18-May-2022 | Insight Guide

Achieving flexibility requires modularity of technologies.

CMOs and CDMOs aspire to be flexible for multiple applications. Efficient automated...

Strategic Approach to Immunogenicity Assessment

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

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

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;...

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