|
|
|
| home > white papers > Points to Consider When Developing a TMF (Trial Master File) Strategy - Phlexglobal Ltd |
|
|
 WHITE PAPERS |
|
Phlexglobal Ltd
|
|
Points to Consider When Developing a TMF (Trial Master File) Strategy
|
|
Many organizations are currently outsourcing clinical trial activities
to one or more contract research organizations (CROs). This strategy
enables companies to leverage specialized expertise and take advantage
of flexible resourcing throughout the conduct of a clinical trial.
Outsourcing minimizes the costs of recruiting experts, building a team
and maintaining an infrastructure. However, it can also add complexity
as the organization looks to meets its compliance obligations regarding
clinical trial documentation.
The documentation referred to in
Article 15(5) of Directive 2001/20/EC as the trial master file shall
consist of essential documents, which enable both the conduct of a
clinical trial and the quality of the data produced to be evaluated.1
This essential study specific documentation is also known as the TMF. As
organizations try to minimize their reliance on paper files, the
electronic TMF (eTMF) has emerged. A current industry initiative to
standardize the organization of this content is known as the TMF
Reference Model. This model is helping standardization efforts across
paper and electronic systems.
As companies implement outsourcing
strategies, CROs and sponsor organizations look for a common foundation
on which to build their TMF capabilities. The following paper outlines
some of the challenges organizations face when outsourcing clinical
trial activities to multiple contract research organizations and a
strategy to facilitate partnering and management of trial information
between sponsors and CROs.
|
|
|
|
|
|
|
|
 |
News and Press Releases |
 |
Wool packaging firm’s green scheme goes ‘beyond recycling’
An award-winning company that has spent more than 10 years innovating in
sustainable packaging has launched a scheme that it says goes ‘beyond
recycling’ – by allowing the end user to return their packaging directly
to them to be used again.
More info >> |
|
 |
White Papers |
 |
|
Shipping with Active Packaging Containers: Three Pre-flight Decisions that Impact the Success of High-value Global Shipments
World Courier
It is the dead of winter in the northern hemisphere and the height of summer in the southern, with external temperature fluctuations exceeding 50 degrees. Flight delays have added precious days to the transport of your multi-million dollar shipment of blockbuster drug from South East Asia destined for Russia. In France, the roads are closed for days due to a monster snowstorm, with your irreplaceable shipment of investigational drugs stopped somewhere en route between Paris and the clinical trial site. Will all be lost, or can informed choices made before the shipment departs ensure product safety despite unforeseen circumstances?
More info >> |
|
 |
Industry Events |
 |
SAPHEX 2019
23-24 October 2019, GALLAGHER CONVENTION CENTRE, 10 RICHARDS DRIVE, HALFWAY HOUSE, MIDRAND, 1685, SOUTH AFRICA
SAPHEX 2019 will be held on the 23rd-24th October at the Gallagher Convention
Centre, Johannesburg, South Africa.
More info >> |
|
|
|
