Authors
Latest:
Understanding Non-AdherenceInappropriate calendar pacakaging is a common occurrence leading to confusion and mistakes.
Latest:
Emerging Opportunity in GuatemalaGuatemala is multi-ethnic, multilingual, and multi-cultural-ideal for international trials.
Latest:
Risk Assessment and MitigationA quantitative approach to enhancing risk assessment and mitigation in drug development.
Latest:
Planning for Success: Global Oncology TrialsMany pharmaceutical, biotechnology and medical device companies have adopted globalization as a business model for their clinical trials. This model is especially pertinent within oncology with the number of competing trials consistently rising while patient access across North America and Western Europe has plateaued. While this geographic diversity of oncology trial sites has potential to open future markets, it also adds logistical hurdles ranging from import and export licenses to regulatory approval to variances in standard of care. This white paper explores several of the areas critical to the success of global oncology trials, including study planning, conducting feasibility and navigating regulatory submissions.
Latest:
Tailored Latino RecruitmentSurvey results show that the recruitment of Latino subjects requires specialized tactics.
Latest:
PK in Late Phase TrialsCollecting PK data in late phase trials led to alleviating additional trials, drug approval, and better dosing.
Latest:
How to Address—and Overcome—Operational Challenges in Master Protocol StudiesTrials that address multiple questions simultaneously using a master protocol can be operationally complicated. These complexities can be managed, even in studies used to support a marketing application.
Latest:
PK in Late Phase TrialsCollecting PK data in late phase trials led to alleviating additional trials, drug approval, and better dosing.
Latest:
Enrollment: More Than NumbersPartnering with CROs and using a blinded independent central review can increase trial success.
Latest:
PK in Late Phase TrialsCollecting PK data in late phase trials led to alleviating additional trials, drug approval, and better dosing.
Latest:
Re-Imagining CTMSClinical professionals can recreate CTMS by applying modern technology in a new way.
Latest:
The Observation Study ConundrumConducting observational studies is becoming a vital part of the clinical trial process, but research teams often struggle to operationalize these more creative and non-traditional study methodologies.
Latest:
Language & Culture in Global Clinical TrialsWith more clinical trials conducted overseas, sponsors are facing new obstacles.
Latest:
Pharmacovigilance AlliancesThe best relationships between sponsors and contractors are those that are well defined from the outset.
Latest:
PK in Late Phase TrialsCollecting PK data in late phase trials led to alleviating additional trials, drug approval, and better dosing.
Latest:
Bridging US and China to Conquer CancerDuring the annual ASCO meeting in June, the US Chinese Anti-Cancer Association (USCACA) held its fourth annual meeting to discuss the emerging role of China in global clinical development of novel anti-cancer drugs.
Latest:
Enrollment: More Than NumbersPartnering with CROs and using a blinded independent central review can increase trial success.
Latest:
PK in Late Phase TrialsCollecting PK data in late phase trials led to alleviating additional trials, drug approval, and better dosing.
Latest:
Bridging US and China to Conquer CancerDuring the annual ASCO meeting in June, the US Chinese Anti-Cancer Association (USCACA) held its fourth annual meeting to discuss the emerging role of China in global clinical development of novel anti-cancer drugs.
