does not participate in day by day activities
keeps track of a clinical project from scratch until the Final Study Report
has been signed off
We deem it necessary that a competent medical writer will be most successful if he both
To provide support throughout the study the Medical Writing Department is headed by a senior and experienced research person, and is therefore reponsible not only for establishing the trial protocol and the case report form, but also for watching the trial go on and participating in the routine communication with the monitors. GCP says that all information should be documented in writing. However, we all know that this does not reflect the truth. It is mandatory that one person can really reflect the background of the study, from the basic idea throughout its entire course. The final study report is written in close cooperation with the statistical department.
It is well understood that we observe all formats and SOPs given by the sponsor and needless to mention, all documents are proofread by a native speaker.
Study Protocol
biometrical study planning and sample size calculation
protocol according to ICH, national laws and indication-specific guidelines
Case Record Form (including electronic diary)
CRFs come in high quality printing with multilingual documentation pages fitting the need of virtually all multinational trials. CRFs have been delivered to all continents - reliably, in time and precise in wording.
a complete data recording acc. to ICH-GCP
an easy and unambiguous data entry by investigator
legible corrections/additions during monitoring
clear correlation to database entries
layout with PageMaker, other programs on request
Oracle based electronic CRF in CRF-layout (e.g. for studies which run with paper CRFs and RDE in parallel)
Patient Diaries
Paper diaries have been used for many years but were never totally reliable because of the quantity of queries and errors that significantly impacted the speed of data collection and the quality of data provided. Accurate data is critically important at each step in the trial process, not just because clinical studies are audited by authorities, but more importantly, because the research findings help to improve patients' overall health and well-being.
ECRON offers as an option the possibility for its customers to use Electronic Patient Reported Outcomes Diary solutions (ePRO) which will improve data quality and patient compliance and shorten the time of clinical trials.
The following e-Diary (ePRO) solutions are available at ECRON:
These solutions are all validated 21 CFR Part 11 compliant technologies. The method of audio transfer used by the Symfo is the most reliable and easiest
data transfer solution available in the market today. To send data, the patient
simply picks up the handset of a regular household telephone, dials a toll-free
number, and places the e-Diary next to the receiver. The server answers the
call using sounds that are interpreted by the e-Diary, which in turn sends encrypted
data. The entire transmission takes about two minutes, depending on the amount
of data. Since the study participants dial a toll-free number, there is no charge
to them to send data. The sponsor pays on a per-call basis. There is no additional
modem equipment to purchase, and no expensive monthly telecom charges. Symfo,
with offices in Cambridge, Massachusetts, and Brussels, Belgium, is the only
vendor to currently offer this innovative data transmission option.
In order to better meet the needs of the customers, Symfo has recently developed SymPhone,
a Java (J2ME) smartphone supporting Unicode and capable of recording patient data the same
way as the SymQuest diary. SymPhone can be used to record either short or long questionnaires
by study subjects in real-time, allowing for higher quality data – and improved patient compliance.
Pictures can also be easily integrated, when necessary. SymPhone uses secure GSM (Global System Mobile)
wireless technology for data transfer.
For more information please visit Symfo
Report
statistical evaluation
graphs of main results
biometrical statement
complete documentation of the study design and methods
reporting of results
professional documentation
statement of clinical relevance
discussion
Furthermore we offer support for