Lonza Small Molecules | 28-Mar-2023
| Technical / White Paper
A growing number of new chemical entities are highly insoluble, leading to problems with bioavailability. Drug manufacturers therefore have to find ways...
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On April 15, 2022, the U.S. Food and Drug Administration issued a new draft guidance to clinical research sponsors on creating a plan to enroll more participants...
Indena’s Custom Development & Manufacturing Organization services offer a full range of manufacturing capabilities for pharmaceutical ingredients including...
Elligo Health Research® | 10-Mar-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...
89% of research sponsors currently use and expect to continue the use of decentralized technologies and methods, according to our state of the industry...
With clinical study activity increasing across the Asia-Pacific region, it is important for sponsors—both in APAC and globally—to understand the broader...
Discover the trends shaping clinical trial technology in 2023, from Site Enablement to eISFs, integrations, and site-sponsor collaboration. This report...
Thermo Fisher Scientific - Process Liquid Preparation Services | 21-Feb-2023
| Technical / 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...
Piramal Pharma Solutions | 16-Feb-2023
| Technical / 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...
The use of consistent terminology within and between studies is critical to enabling an efficient trial process. CDISC standards such as CDASH, SDTM, SEND...
Thermo Fisher Scientific – Production Chemicals and Services | 09-Feb-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...
Health Canada certifies Sofgen Pharmaceuticals in Canadian Good Manufacturing Practices (GMP) for our compliance with the Food and Drug Regulations at...
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...
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...
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...
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)...
Piramal Pharma Solutions | 15-Nov-2022
| Technical / White Paper
Operational Excellence (OE) is a key element of organizational leadership and intelligence. For a CDMO operating in the pharmaceutical industry, OE focuses...
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...
JRS PHARMA | 29-Oct-2022
| Technical / White Paper
The aim of this study was to investigate the disintegration behavior of croscarmellose sodium (CCS), sodium starch glycolate (SSG) and crospovidone (PVPP).
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...
Altasciences | 25-Oct-2022
| Technical / White Paper
Bringing new drugs to market, from lead candidate selection through preclinical testing, to clinical proof of concept, is a complex, time-consuming, and...
Procaps Group, a Leading Global Pharmaceutical company specializing in offering Contract Development and Manufacturing Services in advanced Softgel technologies...
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...
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...
Baxter’s BioPharma Solutions business supports leading pharmaceutical companies in meeting their commercialization objectives by providing scientific expertise,...
Having a team of individuals with specialized expertise in different areas of clinical supply—from protocol review and early operational planning, to managing...
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...
This study aimed to compare the performance of VIVAPHARM® PVP K25, VIVAPHARM® PVP K30, and VIVAPHARM® PVP K90 respectively as wet-granulation binders in...
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...
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...
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...
As the effects of the pandemic reverberate through global supply chains, Sponsors still face many hurdles in sourcing and managing ancillary supplies for...
JRS PHARMA | 01-Jul-2022
| Technical / White Paper
The aim of this study was to investigate the influence of different commonly applied lubricants and disintegrants on tablet surface and film coating adhesion....
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...
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...
More than 2.3 million people are living with MS worldwide. Although there is no cure, new research and innovative treatments are continuously emerging....
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...
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...
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...
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....
