Join us on November 10th for this webcast being held in partnership with RAPS. The Clinical Trials Regulation (CTR) for the European Union (EU) took effect on 1월 31, 2022. Sites and sponsors must now embrace the new regulations to successfully run clinical trials across the European Union. Beginning on January 31st, 2023, sponsors are … Continued
Next generation therapeutics Oligonucleotide drugs are unique among therapeutic modalities in that they don’t engage the disease modulating proteins directly but instead target their encoding mRNA (read more about how “oligos” work in this blog). The benefits of this approach are manifold. First, from the synthetic chemistry point of view, different drugs can be assembled … Continued
Creating CDISC domains as part of the pharmacokinetic (PK) deliverable for regulatory submissions can be a time-consuming, error prone and complex task. Certara’s software PK Submit provides a compliant solution that keeps research teams from tedious data handling. With its ability to create a complete electronic PK regulatory submission package in minutes the software saves … Continued
Drug developers are continuously searching for new ways to improve and expedite biopharmaceutical R&D, inform decision-making, and gain a greater understanding of disease pathophysiology. One of the most promising new disciplines enabling all the above is quantitative systems pharmacology (QSP), a relatively new approach that can predict clinical outcomes for novel targets, modalities, and combinations. … Continued
Historically, the dosing strategy for oncology drugs focused on the maximum tolerated dose. This has resulted in drugs’ pharmacokinetic (PK) profiles, pharmacokinetic/pharmacodynamic (PK/PD) relationships, and clinical target inhibition largely being ignored. Thus, cancer patients often struggle to tolerate their medication doses long-term, requiring dose modifications including dose reductions and holidays. Project Optimus was initiated by … Continued
When it comes to disclosing data from clinical trials of investigational drugs to the public, the vernacular may seem just as confusing as the process! The terms “anonymization” and “redaction” are used interchangeably regarding transparency and disclosure of clinical trial data. But what are the differences in technique or method behind each? We may think … Continued
Choosing the right technology and services vendor to support your organization’s transparency and disclosure (T&D) requirements to health authorities is a critical decision. The vendor selection process varies greatly. Some organizations have rigorous prescribed procedures, while others boast a less formal, less structured process. You need to select a vendor who will help to maintain … Continued
Outside of protecting study participants’ personal information (PI) within clinical research publications, pharmaceutical organizations should avoid disclosing company-related secrets and procedures which could aid their competitors in gaining market advantage. This type of information is called Commercially Confidential Information (CCI) by the European Medicines Agency (EMA) or Confidential Business Information (CBI) by Health Canada (HC). … Continued
For the first time, the European Medicines Agency (EMA) has passed new regulations to help patients understand the results of clinical trials of investigational drugs that they volunteer for. Known as EU-CTR (European Union Clinical Trial Regulation 536/2014), these regulations require a Plain Language Summary (PLS) or “Lay” Summary for every clinical trial conducted in … Continued
Under European Union Clinical Trial Regulation 536/2014 (EU-CTR), replacing the EU Clinical Trial Directive (Directive 2001/20/EC), drug developers must now anonymize or redact clinical trial documents at the same time they are preparing them for regulatory submission (read more about the redaction process in this blog). This makes complying with transparency and disclosure requirements necessary … Continued
