Spark
Spark

SPARKling Service

 

Feasibility and site selection

Feasibility is key to conducting a successful clinical study. I can provide detailed feasibility information and advice according to your needs to ensure you find the sites that deliver what your project needs. I have an open and friendly approach and am here to guide Investigator Sites through the recruitment process every step of the way. Throughout the years I have established good relationships with the major hospitals in my area. I performed numerous on site selection visits, giving me the ability to quickly analyze if a site is suitable for your project.
 

 

Maintaining high patient recruitment

Frequent contacts with investigators and study coordinators, identification of recruitment obstacles to ensure timely recruitment of patients.
 

Audit preparation and support

Throughout the conduct of a clinical trial, I take active measures towards maintaining quality to avoid surprises during audits. This includes direct project responsibility by investigators and continuous training. I am used to faciliting audits onsite and at CROs (including follow up on audit reports).
 

 

Mentoring and developing junior CRAs

Do your own CRAs need some extra guidance or training. Do you need an experienced CRA to accompany your less experienced CRA onsite? I enjoy sharing my experience and efficient approach with junior colleagues.

 

Site initiation training

After the initiation my sites must be ‘ready-to-go’. Initations for me are ‘hands-on’ trainings, highly interactive to ensure the site teams feel ready to recruit your first patient as soon as possible. Elimination of any obstacle that could slow down recruitment.
 

Site monitoring services

I have a strong scientific and medical background and a large experience in clinical trials. Well organized and time-efficient, I deliver quality deliverables in a timely manner with transparency in every single step. I perform risk based, remote and on-site monitoring in accordance to ICH-GCP.
 

Trial master file maintenance

I can take care of the preparation, collection and distribution of the required essential documents for your project in a trial master file. I also take care of maintenance of investigator site files.
 

 

Site close out

During the final monitoring visit, I ensure appropriate closure of your sites and reporting to EC and authorities. I deliver a high quality study file that is audit/inspection proof.
 

Clinical team management – lead CRA tasks

Seen my broad experience over many years, I can take on limited management tasks: take leadership in clinical issues, train other CRAs, resolve vendor issues.