Technical Papers

688 Results

Enhance your cGMP chemical supply chain

Enhance your cGMP chemical supply chain

Thermo Fisher Scientific – Production Chemicals and Services | 17-Jan-2023 | Technical / 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

Thermo Fisher Scientific – Production Chemicals and Services | 16-Jan-2023 | Technical / 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

Formedix | 16-Jan-2023 | Technical / 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

PPD - Decentralized Clinical Trials | 12-Jan-2023 | Technical / 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

PPD - Decentralized Clinical Trials | 05-Jan-2023 | Technical / 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?

Formedix | 14-Dec-2022 | Technical / 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

PPD - Decentralized Clinical Trials | 13-Dec-2022 | Technical / 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

Formedix | 09-Nov-2022 | Technical / 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

Indena | 25-Oct-2022 | Technical / 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

Formedix | 10-Oct-2022 | Technical / 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

Altasciences | 04-Oct-2022 | Technical / 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...

ODM and CDASH in CRF design

ODM and CDASH in CRF design

Formedix | 15-Aug-2022 | Technical / 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...

dPCR Case Study

dPCR Case Study

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...

Standardizing data with NCI controlled terminology

Standardizing data with NCI controlled terminology

Formedix | 18-Jul-2022 | Technical / 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...

Planning Your First-In-Human Trial

Planning Your First-In-Human Trial

Altasciences | 15-Jul-2022 | Technical / 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

Baxter BioPharma Solutions | 13-Jul-2022 | Technical / 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

Baxter BioPharma Solutions | 13-Jul-2022 | Technical / White Paper

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

How clinical trial software can optimize trials

How clinical trial software can optimize trials

Formedix | 20-Jun-2022 | Technical / White Paper

This article explains the different types of clinical trial software available, and how it can be used to optimize the end to end clinical trials design...

Multiple Sclerosis Analytical Report

Multiple Sclerosis Analytical Report

PatSnap | 15-Jun-2022 | Technical / 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....

Flexible Filling Solution for CMOs

Flexible Filling Solution for CMOs

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

Altasciences | 17-May-2022 | Technical / 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

Veeva | 10-May-2022 | Technical / 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

Formedix | 09-May-2022 | Technical / 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;...

BMS Adopts a New Clinical Data Architecture

BMS Adopts a New Clinical Data Architecture

eClinical Solutions | 31-Mar-2022 | Case Study

In this Case Study, you will learn how Bristol Myers Squibb optimized their data review processes to streamline and improve access to their data. By implementing...

Achieve Clean Data Sets Faster

Achieve Clean Data Sets Faster

eClinical Solutions | 28-Mar-2022 | Case Study

In this case study, you will learn how Karyopharm Therapeutics simplified their data flow and reduced manual work across a diverse pipeline of clinical...

For eCOA Success, Look For The Four S's

For eCOA Success, Look For The Four S's

Signant Health | 21-Mar-2022 | Technical / White Paper

For an effective eCOA platform that can meet any protocol requirements, study teams need more than just an app. Download this perspective paper to learn...

Opportunities to Accelerate Decentralized Trials

Opportunities to Accelerate Decentralized Trials

eClinical Solutions | 21-Mar-2022 | Technical / White Paper

Take a deeper look into the current state of data sources, organization, and analytics in this white paper. You will learn about their impact and the opportunities...

Eastern & Western Manufacturing Solutions

Eastern & Western Manufacturing Solutions

Piramal Pharma Solutions | 15-Mar-2022 | Technical / White Paper

The best manufacturing site for a product can change throughout the life cycle. When bringing new drugs to market, biopharma companies may benefit from...

The Clinical Development Digitization Guide

The Clinical Development Digitization Guide

eClinical Solutions | 07-Mar-2022 | Technical / White Paper

Take a deeper look into the key components of preparing for the digitization of today's clinical trials in this white paper. You will learn the necessary...

Clear Guidelines for IND/CTA

Clear Guidelines for IND/CTA

Altasciences | 24-Feb-2022 | Technical / White Paper

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

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