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Site Management.
ERGOMED has long recognised the value to investigating physicians
of employing on-site staff to assist with the administrative and
management aspects of their study site. From the beginning, ERGOMED
has been primarily concerned with the timely and successful completion
of studies for its clients. If an investigating physician is overloaded
or otherwise unable to perform his/her administrative duties, ERGOMED’s
site management teams are on hand to provide the necessary resources
rather than simply reporting a deficiency.
ERGOMED’s study site coordinators and facilitators have
developed close relationships with their sites and investigators.
These professionals have unique access to investigator site personnel
and information about patient availability, competing
protocols and local policies, thereby strengthening ERGOMED’s
capability to provide a realistic assessment of the feasibility
of protocols and appropriate site selection. They can select investigators
with expertise, patient availability, and other on-site resources
which most closely match study requirements.
Finally, they provide continuous and valuable support for sites
throughout the entire clinical trial process.
Duties of the Study Site Co-ordinator The purpose
of employing Study Site Co-ordinators (SSC) in clinical operations
is to facilitate and expedite the execution of clinical trials
by optimising the utilisation of resources. Their main roles and
responsibilities are inherently linked to those of the study site
and in this capacity they represent ERGOMED’s study site
coordination activities. The role of the SSC is strictly limited
to facilitation of activities related to the study site; the SSC
does not undertake any of the investigational procedures, nor does
he/she interfere with or otherwise assume any of the responsibilities of the investigator or clinical research
monitor.
Duties and Responsibilities of the SSC:
• Operational support to investigators and co - investigators
in clinical study execution
• Maintain timelines by providing high-level support throughout the clinical
study
• Maintain relationships with investigators and co - investigators to optimise
performance of clinical study throughout its duration
• Organise and facilitate site meetings related to clinical study execution.
• Ensuring implementation and follow-up of current “Good Clinical
Research Practices”, policies, regulatory guidance, ERGOMED working processes
• Regularly reporting the status of the site activities and progress to
the investigator
• Undertaking other study specific activities described in study/project
operational plans/documents or timelines
• Providing on-site support to ensure speedy recruitment and timely progress
of a clinical trial
• Ensuring that the clinical study is conducted and reported in accordance
with the protocol, standard operating procedures (SOPs), GCP, and the applicable
regulatory requirements.
Site support typically consists of following activities:
• Collection and classification of medical documentation
• Ordering and maintaining all study specific materials (e.g. glassware,
tubes, assay kits, forms, packaging materials, etc.)
• Assistance to investigators in the organisation and conduct of subject
consent
• Maintaining timetable, diary and log of subjects’ planned visits
and study specific procedures
• Scheduling of study specific procedures
• Contacting and reminding patients of study timetable
• Organisation of shipments and other logistics
• Collection and delivery of biological samples
• etc.,
Ergomed and Study Site Management ERGOMED’s
position as the leader in the successful integration of Site Management
Capabilities into full Clinical Development Services is very highly
regarded by sponsors as well as investigators. Optimal investigator
site contribution is ensured by combining good patient recruitment
with high quality data collection and assistance to investigators
with their many administrative and logistical responsibilities
including scheduling of patient visits, shipment of blood samples
etc.
ERGOMED’s Study Site Coordinators work strictly in accordance
with ICH/GCP and completely independently of CRAs and PMs; they
follow their own SOPs and have a separate line management and reporting
structure.
SSC support to investigators results in:
• more timely data entry
• enhanced data quality
• fewer data queries
• more patients per site
• faster recruitment.
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