Phase I-II

124 Results

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...

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

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...

Automating clinical trials: Why it's essential

Formedix | 05-Sep-2022 | Technical / White Paper

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

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

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

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

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...

Is Your Ancillary Supply Chain Supporting Trial Success?

Ancillare | 06-Jul-2022 | Technical / 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

Piramal Pharma Solutions | 30-Jun-2022 | Technical / 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...

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...

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

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

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;...

What should a clinical metadata repository do?

Formedix | 18-Apr-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...

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

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

Formedix | 28-Mar-2022 | Technical / 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

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...

The APAC Advantages

Catalent Pharma Solutions | 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.

CellCarta - Mapping Precision Medicine

CellCarta | 17-Jan-2022 | Product Presentation

At CellCarta, we’re dedicated to working with our partners to further the limitless potential of precision medicine. Our broad technology offering is designed...

Planning Your Preclinical Assessment

Altasciences | 17-Jan-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...

How a Clinical MDR Helps with Data Quality

Formedix | 17-Jan-2022 | 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...

Automating clinical trials for success

Formedix | 06-Oct-2021 | Technical / 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

World Courier | 15-Jul-2021 | Technical / 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

PerkinElmer | 14-Jul-2021 | Technical / 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?

Medable | 26-Apr-2021 | Technical / 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®

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...

Deploy Configurable, Mixed-Modality ePRO Solutions, Fast

Clinical Ink | 01-Mar-2021 | Data Sheet

Real-Time, Integrated Data Capture With Unprecedented Freedom of Choice

Clinical Trials 2.0: A Fresh Approach to Systems and Data

Cmed | 01-Mar-2021 | Technical / 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...

A Winning End-to-End Solution for Oncology Studies

Clinical Ink | 22-Feb-2021 | Technical / White Paper

Oncology clinical trials present a unique set of challenges for patients, study sites, and study sponsors. Using electronic patient reported outcomes (ePRO)...

Exploring the Intricacies of the Immune System: A Practical Guide to Immune Monitoring Across Therapeutic Interventions

Precision for Medicine | 01-Feb-2021 | Insight Guide

Immune monitoring has become an essential strategy for understanding, predicting, and monitoring the response of the immune system to therapeutic interventions....

Lessons Learned: Clinical Trials During a Pandemic

PCM TRIALS | 01-Sep-2020 | Technical / White Paper

In a recent survey of clinical trial professionals (including pharmaceutical sponsors, CROs, site representatives and vendors), respondents reported that...

Global Pediatric Drug Development Collaboration: Part One

PRA Health Sciences | 09-Jul-2020 | Technical / 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...

Global Pediatric Drug Development Collaboration: Part Two

PRA Health Sciences | 09-Jul-2020 | Technical / White Paper

70% of medicines given to children have never been studied in pediatric populations. Children who need treatments represent a relatively small population....

Laboratory Solutions for COVID-19 Clinical Trials

Q² Solutions | 10-Jun-2020 | Clinical Study

As a leading laboratory services organization for trials across the globe, we are proud to partner with clients to support COVID-19 clinical trials. Our...

Parents as Gatekeepers for Children with Cancer

PRA Health Sciences | 08-Jun-2020 | Technical / White Paper

The RACE for Children Act will require new drugs intended for adult cancer treatment to also be studied in pediatric cancers when the molecular target...

RACE Act Prompts Pediatric Oncology Trials

PRA Health Sciences | 04-May-2020 | Technical / White Paper

Many providers prescribe drugs off-label to pediatric patients, even though there have been few pediatric trials for many of these drugs. In response,...

Manufacturing Cyto and Non-Cyto Drugs in One Facility

Baxter BioPharma Solutions | 01-Mar-2020 | Technical / White Paper

Recent market reports suggest increasing product niches, which may lead to decreasing numbers of units per product, making dedicated facilities less practical....

QPS: Global Custom-Built Research Services

QPS | 16-Dec-2019 | Product Brochure

Performing complex studies in special populations with remarkable agility. Clinical research just got better with QPS’ Custom-Built Research Services....

Outsourcing Analytical Testing for Biologics - A CRO's Perspective

Frontage Laboratories | 01-Dec-2019 | Technical / White Paper

Biologics are complex large molecules derived from living organisms or manufactured from cells, and they have inherent structural heterogeneity. Indeed,...

How to Avoid Surprises in Small-Molecule Drug Development Programs

Frontage Laboratories | 01-Oct-2019 | Technical / White Paper

Over the years, the pharmaceutical industry has made steady progress in improving the safety of drugs in development. Consequently, in 2015, only 14 percent...

Validating The Simoa Technology

Frontage Laboratories | 01-Oct-2019 | Technical / White Paper

Frontage is the first and only laboratory to validate Quanterix’ Simoa HD1 Analyzer for performing immunoassays. Most of the advanced instruments used...

Assessing Pre-Existing Antibodies in Biotheraputic Development

Frontage Laboratories | 21-Aug-2019 | Technical / White Paper

Immunogenicity is the leading reason that biologics fail in clinical trials, and thus it has become imperative for drug development programs to include...

What do big pharma companies spend on R&D?

Zymewire | 15-Aug-2019 | Technical / White Paper

The free Big Pharma R&D Spend report examines the financial performance and research & development investments of the top 25 pharmaceutical companies...

The Truth about Physician Referrals and Clinical Trials

BBK Worldwide | 24-Jul-2019 | Technical / White Paper

Despite growing evidence, the myth that physicians won’t refer patients to clinical trials persists, perpetuated by the belief that they fear losing their...

Survey Report: State of the global pharmaceutical contract services industry 2018

William Reed | 11-Jul-2018 | Research Study

In May 2018 Outsourcing-Pharma.com, in association with InnovoCommerce, conducted its second annual ‘state of the industry’ survey on its user base of...

Next generation ePRO from SQN Health

Syne Qua Non Clinical | 16-May-2018 | Business Advice

In an era of rapid technology growth, healthcare requires low cost solutions for real-time data collection. We have come a long way from paper to EDC and...

Leveraging Best Practices in Primary Packaging

Catalent Pharma Solutions | 05-Mar-2018 | Technical / White Paper

When planning a clinical trial, overlooking the importance of primary packaging can be a mistake. From stability concerns to labeling to patient compliance...

Meet the challenges of complex injectables

Vetter Pharma International GmbH | 07-Nov-2017 | Technical / White Paper

In the time it takes from the exciting discovery phase to the rigorous demands of a commercial launch, unexpected scientific and technical challenges can...

The Power to Make, A Virtual Tour

Althea | 24-Mar-2017

You have the power to make a difference. To make new therapeutics that improve quality of life and inspire a healthier world. To do this, you need a manufacturing...

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