Location & Security

Location

My home office was purpose built in 2010. It is separate from my home, but at the same street address.

From my home office, located in Almere, quite central in the Netherlands, nearly all major cities in the country can be reached within 1.75 hr. Especially during rush hours, public transport offers a good alternative.
Schiphol International Airport is a 40-minute drive away, or 45 minutes by train.

Security

At SIC, your data and files are safe at all times. 
Over the last few years, the following set-up has shown to be effective to this end. Some of these features are specified in the few SOPs I have in place:

– The only cloud-based service used is the MS Office365 suite, of which MS-Outlook is the only app to use a cloud-based archive
– USB storage devices (used both at my office and ‘on the road’) are only used for temporary storage/transfer and are securely wiped right after use
– I back up e-mails and agenda items from my e-mail  app to local storage at least once per week
– To protect against HDD failure, my main pc runs Windows Disk Dynamic Mirror, which is comparable to RAID 1
– A full backup to an external HDD is made every month, after which the drive is stored at an off-site location
– All data on all machines in use (PC and laptop PCs) is encrypted using BitLocker
– I make sure all software used is up-to-date
– Passwords are stored in KeePass which is only used locally
– Paper records: a secure waste paper policy is in place for any printed confidential material, such as drafted reports

About S.I.C.

Smeets Independent Consultant - SIC, is the full name of my/Edgar's company, established in 2003. I am a sole trader, in the Netherlands known as 'ZZP'. The company is registered with the Chamber of Commerce (KvK) number: 39.08.30.34, and is VAT registered. I partner with (bio)pharmaceutical companies, start-ups, Institutions, investigators, or CROs to consult on and assist with a variety of tasks within the clinical research field. All my activities are performed using efficient reporting to my clients (risk-based, lean), and sustained by appropriate follow-up. I have a few SOPs in place myself to cover the topics 'Physical and Digital Security', and 'GDPR; Preventive and Corrective Measures', in my home office. You are kindly invited to explore this website, and please DO contact me with any questions.

Services offered

In general I offer a rather straightforward, efficient set of services when setting up your research project/trial, and represent my client when following through during the execution of the trial(s). I always keep a lean, business-like approach in mind.
The tasks performed by me could be one of the following, by itself or combined:
  • Selecting sites for your research project, preparing each, setting up the logistics, contracts, and applying for regulatory approvals (EC and CA)
  • Central Monitoring, with on-site visits where needed (in line with Risk-based Monitoring approach) (Quality Control)
  • Quality Assurance when setting up your research project, build or refresh your Quality Management System (issue Monitoring Plan, Data Management Plan, etc.)
  • Data Management activities / (extended) Central Monitoring
  • Employ ACTRIS (see elsewhere) to manage any issues / potential risks
  • Train or coach other CRAs/monitors working on the same trial
  • Oversee Safety Reporting, provide follow-up if needed
  • Generally speaking, all the tasks described under item 5.18 of the E6 ICH-GCP guideline
    • In general, when submitting your trial to EudraCT, my name and details will get listed at section G5 of 'Annex 1 Clinical trial Application Form' (G5 sub items 1.9, 1.10, 1.11 and 1.13 answered 'yes').

Contact

On request, I can send you further information, such as a Curriculum Vitae, a recent copy of my training log, a publication list, or my ACRP credentials. Please contact me to have a chat, and to find out my current or future availability.

e.smeets@sic-est.nl
© 2024 Smeets Independent Consultant.