Multinationals,
Biotech, CROs, Research Foundations, Generics
Client Countries
18
Australia,
Belgium, Canada, Cyprus, Denmark, Finland, France, Germany,
India, Ireland, Italy, Japan, Netherlands, Portugal, South
Africa Switzerland, UK, USA
Phase
I and special population PK
44
Incl. 2 first
in man; 6 patient studies; 8 vaccine (of which 4 HIV)
Phase
II
46
Of which 12
Proof of Concept IIA
Phase
III
23
Extension
Studies
6
Phase
IV
4
Bioequivalence
19
Other
5
Sites
in countries
7
South Africa,
Kenya, Uganda, Tanzania, Rwanda, Botswana, Zambia
Sites
managed
493
Sites
per study
Range
1
to 40
Total
Participants
>27000
Participants
per study
Phase
I/Bioequiv
10
to 60
Phase
II
32
to 220
Ph
III/IV
200
- 8000
Epidemiology
2240
Tasks
Contracted to Triclinium
Protocol
Input
14
Regulatory
(MCC, ECs and Biosafety for GM biologicals)
78
Regulatory
submissions
72
Approved
first review (5 – 18 weeks)
5
Currently
under preparation or review
1
Delayed
approval
0
Approvals
refused
Organise
Investigator Meetings
36
Complete
organisation by Triclinium (10 – 140 delegates)
Proj.
Management
98
14 Entire study in southern Africa5 Regional part of multinational
study
Monitoring
130
Range
1 to 11 monitors per study
QA
Audits
12
Sites
and Vendors
IND
Studies
7
Audits
undergone
23
2 FDA (sites
audits)
17 Sponsor (sites and Tri)
4 Lead CRO (sites and Tri)
Client
References
Please e-mail
us if you wish to contact any of our previous
clients.
Staff 
