Recruitment Service:

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.

Sponsor Companies                                               

Abbott Laboratories (Pty) Ltd

AstraZeneca

Bristol-Myers Squibb

Eli Lilly and Company

Pfizer Laboratories (Pty) Ltd.

Sanofi-Aventis

Servier Laboratories South Africa (Pty) Ltd

Eisai Co., Ltd

Clinical Research Organizations

PAREXEL International

QdotPharma

Quintiles

PPD

Intregrium Clinical Research

CATO Research

 

Management

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

 

Clinical Conduct

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

 

Quality Assurance

AQ   001  SOP:  Quality Assurance