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| home > white papers > Conveying Medical Guidance in Clinical Trials – A Survey - Europital Medical Consultancy |
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 WHITE PAPERS |
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Europital Medical Consultancy
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Conveying Medical Guidance in Clinical Trials – A Survey
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With the incremental demand for proactive safety surveillance throughout
the conduct of clinical trials, the role of Medical Management is at
the fore in ensuring the safety and wellbeing of the participants. The
complex responsibilities of a Medical Monitor (MM) starts from the
design and development phase, through to study close out. Understanding
the principle behind the protocol and the prospective medical solution
the study would deliver forms the bloodline for the MM role. Often, the
MM is the face of contact for both the site personnel and the study team
members with regard to medical, safety and scientific issues within the
project.
When it comes to medical guidance, the communication channel used to
deliver solutions contributes to a large extent in effectively managing
decisive situations. Our previous study on acquiring medical guidance
from an operations team perspective revealed that e-mails were the most
used communication method (see the article, 'Talking Points', in ICT November 2014). In our efforts to further strengthen the mode of medical
guidance delivery, we designed a survey to study the existing trend and
constraints in this communication chain management, as outlined here.
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News and Press Releases |
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Lynparza recommended for approval in EU by CHMP for BRCA-mutated metastatic pancreatic cancer
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck
& Co., Inc. inside the US and Canada) today announced that Lynparza (olaparib) has been recommended for marketing authorisation in the
European Union (EU) for the 1st-line maintenance treatment of patients
with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer.
The
Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) based its positive opinion on results from the
Phase III POLO trial, which were published in The New England Journal of Medicine.
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White Papers |
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Clinical Trials in Russia Orange Paper: 1st Quarter 2014
Synergy Research Group
In summary, Russia remains a very popular geography for local, regional, and global pharmaceutical companies to conduct clinical trials. Sponsors mention the following reasons for conducting studies in Russia:
1. Fast patient enrollment due to the centralized medical infrastructure.
2. Nearly 100% patient retention
3. GCP trained and certified Investigative Sites generating high quality data
4. Low cost: Average per patient cost is 60% to 70% below US and European prices due to the low cost of Investigators and the high concentration of patients in therapeutically aligned medical centers
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Industry Events |
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Clinical Operations in Oncology Trials West Coast
17-18 November 2020, Hilton San Francisco Airport Bayfront
Clinical Operations in Oncology Trials West Coast will be returning this April for another 2 day event full of thought-provoking presentations, discussions and roundtables. This years' conference highlights include the high-level, interactive immuno-oncology discussion panel where specialists from Shasta Bio Ventures, Abbvie and BeiGene shared their top tips on how to run successful and impactful immuno-oncology studies.
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