Technical Papers

711 Results

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.

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...

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...

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...

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