Services

Services

Study Start-Up

Investigator Brochure & Protocol Development

Our medical and scientific experts can help you develop an Investigator’s Brochure and protocol (or revise an existing one) in order to educate participants on the study and its requirements.

 

Feasibility: site assessment, selection and identification

Our feasibility approach combines our knowledge of a potential site’s performance history and the clinical care provided at the site to patients. We know those sites with strong patient-provider relationships yield a higher rate of conversion to study participants. We begin with a review of a study plan to develop a dynamic feasibility questionnaire to gather the initial information required to make informed decisions on site selection. We then follow our proven processes for site identification, selection and qualification.

 

Essential Document & Trial Master File Management

The timely collection of key documents is essential to ensure an efficient start-up of your clinical study. Ongoing maintenance of audit-ready Trial Master Files bring transparency and compliance with Good Clinical Practice.

Investigator Contract Negotiation & Grant Management

We work with both the sponsor and the site managers to ensure that the financial arrangements mutually work for both parties. Our Clinical Trial Management System allows for simple management of investigator grant payments.

 

Institutional Review Board/Institutional Ethics Committee Submission

Our operations team works with both central and local ethics committees in order to ensure that all our clinical studies start on time and meet the standards required for ethical approval.

 

Patient Recruitment

As a premium North American patient recruitment provider, Topstone holds a thorough understanding of international clinical trial regulations, online marketing rules and privacy laws. We employ a targeted approach to patient recruitment, combining a mix of web-based advertising, study websites, patient portals, media placement and a call centre for rapid and effective recruitment. Backed by an operationally focused, experienced recruitment team, Topstone most recently increased awareness by 600% for a clinical study, resulting in one of the industry’s fastest enrollment execution plans.

 

Study Conduct

Clinical Monitoring

We select Clinical Research Associates from a staff pool who are experienced in a particular field of study and who are geographically located where the study is taking place.

 

Drug Safety

Our pharmacovigilance teams have expertise and experience in Serious Adverse Event collection and reconciliation; narrative writing; MedWatch/CIOMS & ISL generation; as well as Institutional Review Board and Regulatory Authority Submission.

Project Management

Our project managers work closely with our clients and vendors in order to ensure that our team is meeting the timelines and budget requirement outlined in the contract.

 

Quality Assurance

Our independent quality assurance group can perform third party audits and also ensure that all processes comply with our policies, regulatory guidelines, and the study protocol.

 

Medical Monitoring

Our Medical Monitoring team is available 24/7 to support the investigators and their staff providing you with experienced research physicians to assist in managing the sites and project.

Facilities

We have two Clinical Trial Centres, both with multi-disciplinary medical clinics as part of the Topstone Research family. In addition, we have strategic alliances with large practice management groups across Canada, providing access to 60 sites and more than 500,000 patients. Contact us today to learn more.