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....
Content provided by Altasciences | 02-May-2023
| White Paper
As a leading partner in central nervous system (CNS) drug development, Altasciences’ in-house preclinical, clinical, bioanalytical, and manufacturing teams...
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...
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...
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....
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...
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...
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...
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...
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On April 15, 2022, the U.S. Food and Drug Administration issued a new draft guidance to clinical research sponsors on creating a plan to enroll more participants...
Content provided by Indena | 15-Mar-2023
| White Paper
Indena’s Custom Development & Manufacturing Organization services offer a full range of manufacturing capabilities for pharmaceutical ingredients including...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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)...
Content provided by Piramal Pharma Solutions | 15-Nov-2022
| White Paper
Operational Excellence (OE) is a key element of organizational leadership and intelligence. For a CDMO operating in the pharmaceutical industry, OE focuses...
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...
Content provided by JRS PHARMA | 29-Oct-2022
| White Paper
The aim of this study was to investigate the disintegration behavior of croscarmellose sodium (CCS), sodium starch glycolate (SSG) and crospovidone (PVPP).
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...
Content provided by Altasciences | 25-Oct-2022
| 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...
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...
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...
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...
Content provided by JRS PHARMA | 01-Aug-2022
| Clinical Study
This study aimed to compare the performance of VIVAPHARM® PVP K25, VIVAPHARM® PVP K30, and VIVAPHARM® PVP K90 respectively as wet-granulation binders in...
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...
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...
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...
Content provided by Ancillare | 06-Jul-2022
| 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...
Content provided by JRS PHARMA | 01-Jul-2022
| 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....
Content provided by Piramal Pharma Solutions | 30-Jun-2022
| 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...
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....
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...
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...
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...
