Excellentis Clinical Trial Consultants offers a web-based recruitment service, in addition to a telephonic patient recruitment and screening call-centre, for South African clinical studies.
We have an in-depth understanding of the clinical trial process and our hands-on experience in recruitment and conducting clinical studies makes it possible to work as a team, together with the Sponsor, CRO and study sites.
The use of a call centre affords us the opportunity of immediate response to a large number of telephone calls, which might otherwise be lost, due to busy Study Co-ordinators and Investigators.
A call centre facilitates communication with patient volunteers, enabling us to provide them with the necessary details and response.
Our data-capturing methods permit a detailed analysis of the effectiveness of media advertising, so as to maximise budgets, and attract the greatest possible number of suitable patients.
Site Management Service:
Our site management service business concept was the basis upon which we developed Excellentis Clinical Trial Consultants
It is an accepted fact that Specialists are too involved in busy practices to conduct research on their own. By providing an experienced, dedicated management team, we enable motivated medical practitioners to participate, thereby contributing to new medical treatments that improve quality of life.
In managing clinical research trials, Excellentis Clinical Trial Consultants integrate the skills of experienced Investigators with the expertise of a cohesive professional team, thus ensuring rapid patient enrolment and reliable data.
Communication is centralised, and team members are informed of all research activities in real time.
One of the directors of Excellentis Clinical Trial Consultants takes responsibility to complete the feasibilities for potential clinical studies, in cooperation with the investigators with the requisite expertise, to meet extremely short time-lines, while reflecting the true capabilities of the site.
Contracts are negotiated with an Excellentis Clinical Trial Consultant Director, who liaises with the Principal Investigator.
Data-clarification forms are despatched within the relevant given time-lines, and electronic data-completion likewise takes place within expected time-frames.
Besides all the usual activities associated with conducting clinical research projects, the committed management team provides continuous on-site management for revising and up-dating the Standard Operational Procedures (SOP’s), maintaining and calibrating equipment, and ensuring that clinical work at the site adheres to stringent international quality standards.
Abbott Laboratories (Pty) Ltd
Eli Lilly and Company
Pfizer Laboratories (Pty) Ltd.
Servier Laboratories South Africa (Pty) Ltd
Eisai Co., Ltd
Clinical Research Organizations
Intregrium Clinical Research
ADM 001 Writing and Reviewing of SOP’s
ADM 002 Change Control for Revising or updating SOP’s
ADM 003 SOP: Investigator and Clinical Staff training
ADM 004 SOP: Computer System management
ADM 005 SOP: Document Control
ADM 006 SOP: Equipment calibration
CCT 001 SOP on Obtaining Informed Consent from Clinical Trial Participant and where applicable Caregiver
CCT 002 SOP on doing an ECG in resting supine position
CCT 003 SOP: Procedure to record Vital Signs
CCT 004 SOP: Recording of height and weight
CCT 005 SOP: Interview to obtain demographic information, family-, medical-, and social history
CCT 006 SOP: Physical and Neurological examination
CCT 007 SOP: Blood samplings through vena puncture
CCT 009 SOP: Urine sampling
CCT 010 SOP: Management of oral investigational product
CCT 011 SOP: Development of Source data documents and keeping source data
CCT 012 SOP: Patient transport fees
CCT 013 SOP: Reporting Serious Adverse Events
AQ 001 SOP: Quality Assurance