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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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PCI Pharma Services Announces Appointment of Angi Calkins as Chief Human Resources Officer
Philadelphia, PA – January 28, 2019. Leading biopharmaceutical services provider PCI Pharma Services (PCI) is pleased to announce the appointment of Angi Calkins as Senior Vice President and Chief Human Resources Officer. Angi joins PCI as the company experiences considerable growth and global expansion, currently with more than 3,500 associates, spanning eight locations comprised of 20 facilities across three continents. PCI features a broad portfolio of outsourced development and commercialization services focused in drug development and manufacturing, clinical trial supply, as well as commercial contract packaging.
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White Papers |
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Detecting Integrity Breaches in a range of Pharmaceutical Blister Package Types using Sepha VisionScan
Sepha Limited
Demonstrating the integrity of pharmaceutical blister packs is critically important, as any defects can affect the shelf life and efficacy of the contents. Compared to bulk packaging, blister packs offer improved product integrity, tamper evidence and reduce the likelihood of misuse. Packs can be composed of either a thermoformed polymer or cold formed aluminium tray, with a number of individual pockets to hold the product. After the tablets or capsules are placed in the pockets, the packs are heat sealed with a paper or foil laminate sheet. These various stages can be completed separately or integrated into a single form, fill and seal process. There is a risk of microbial containment or degradation of the contents if any defects are present in the packaging. Such defects can take the form of rips or pinholes in the tray, or lid materials, faulty seals and channel leaks between pockets.
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Industry Events |
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PDA Europe Annual Meeting 2019
24 June 2019, Hilton Amsterdam
Featuring updates from international regulatory agencies as well as industry, this promises to become another highlight in the 2019 event calendar and is a meeting not to be missed!
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