Our Services
What can we do for you?
AddClin Research offers the following services, which are undertaken according to the South African GCP Guidelines and ICH GCP:
We can guide you throughout the process of running a clinical trial by putting together a total package for your next study, with the following services:
- Intensive Project Management on each study
- Study design development
- Expert input into proposed designs
- Medical writing: Protocols, Amendments and Final Study Reports
- Obtaining Independent Ethics Committee (IRB) approval
- Obtaining Medicines Control Council (Regulatory) approval
- Case Report Form (CRF) design and recording
- Recruitment of dedicated volunteers
- Subcontract safety laboratories through SANAS accredited laboratories
- Clinical execution
- Investigational product handling and administration
- Medical evaluation and safety reporting
- Sample processing in accordance with Good Laboratory Practice
- Bio-analytical services through our strategic partners
- Biometrics, statistical analysis and reporting through our strategic partners
- Total Quality Management - Quality Control and Quality Assurance in addition to site staff commitment to producing quality work on a daily basis.
- GCP training for clinical operations personnel
Capacity and Infrastructure.
AddClin Research offers a world-class infrastructure to its clients in its pursuit to become a dominant role player in the clinical trials industry in the international arena:
- 36–bed ward, floor area 487 square metres; 4 different sections which can be used to separate men and women, separate gender cloakrooms
- Facilities for leisure activities.
- Emergency and other resuscitative equipment
- Dispensing unit with environmental and access control and temperature controlled fridge
- Two screening rooms
- Phlebotomy and informed consent room
- Admin/ Monitor’s office
- Sample processing laboratory with centrifuges, freezers and area for tube labelling.
- Kitchen
- Safety laboratories are outsourced to a local SANAS accredited, GLP compliant laboratory approximately 15 km from clinical trial centre
- Comprehensive IT infrastructure and network
- Dependable communication through landlines, mobile phones, faxes, bulk sms messaging, e-mail and high speed Internet
- Bio analytics and Biometry is outsourced to reputable, local and international institutions
Access to subjects
- AddClin research is geographically well positioned and allows us to target 10 tertiary institutions within a 30 kilometre radius, giving us a large student population. AddClin Research has an extensive database of active healthy volunteers, with a record of their clinical history.
- AddClin Research has access also to a patient population through the Synexus SA network of affiliated sites, use of advertising and patient recruitment strategies.
- We are able to lease with health care professionals and primary health care clinics, which ensures effective co-operation in the conduct of clinical trials.
IP storage/dispensing
AddClin Research has the staff, expertise and storage facilities allowing for a secure, temperature and humidity controlled dispensary unit, which enables us to manage investigational supplies according to GCP guidelines and national guidelines. Three staff members have recently completed the dispensing course.
Highest Quality is achieved through:
- Ongoing training, documented in Training Records
- Formal instruction on Standard Operational Procedures
- Ongoing training / refresher courses eg. CPR for clinical staff
- GCP Trained clinical staff
- Internal Quality Control and audit
- A comprehensive set of Standard Operational Procedures (SOP’s) is in operation to ensure that every aspect of clinical research is conducted in accordance with ICH GCP guidelines.
- Favourable sponsor audits and South African MCC inspection.
Our Services
What can we do for you?
AddClin Research offers the following services, which are undertaken according to the South African GCP Guidelines and ICH GCP:
We can guide you throughout the process of running a clinical trial by putting together a total package for your next study, with the following services:
- Intensive Project Management on each study
- Study design development
- Expert input into proposed designs
- Medical writing: Protocols, Amendments and Final Study Reports
- Obtaining Independent Ethics Committee (IRB) approval
- Obtaining Medicines Control Council (Regulatory) approval
- Case Report Form (CRF) design and recording
- Recruitment of dedicated volunteers
- Subcontract safety laboratories through SANAS accredited laboratories
- Clinical execution
- Investigational product handling and administration
- Medical evaluation and safety reporting
- Sample processing in accordance with Good Laboratory Practice
- Bio-analytical services through our strategic partners
- Biometrics, statistical analysis and reporting through our strategic partners
- Total Quality Management - Quality Control and Quality Assurance in addition to site staff commitment to producing quality work on a daily basis.
- GCP training for clinical operations personnel
Capacity and Infrastructure.
AddClin Research offers a world-class infrastructure to its clients in its pursuit to become a dominant role player in the clinical trials industry in the international arena:
- 36–bed ward, floor area 487 square metres; 4 different sections which can be used to separate men and women, separate gender cloakrooms
- Facilities for leisure activities.
- Emergency and other resuscitative equipment
- Dispensing unit with environmental and access control and temperature controlled fridge
- Two screening rooms
- Phlebotomy and informed consent room
- Admin/ Monitor’s office
- Sample processing laboratory with centrifuges, freezers and area for tube labelling.
- Kitchen
- Safety laboratories are outsourced to a local SANAS accredited, GLP compliant laboratory approximately 15 km from clinical trial centre
- Comprehensive IT infrastructure and network
- Dependable communication through landlines, mobile phones, faxes, bulk sms messaging, e-mail and high speed Internet
- Bio analytics and Biometry is outsourced to reputable, local and international institutions
Access to subjects
- AddClin research is geographically well positioned and allows us to target 10 tertiary institutions within a 30 kilometre radius, giving us a large student population. AddClin Research has an extensive database of active healthy volunteers, with a record of their clinical history.
- AddClin Research has access also to a patient population through the Synexus SA network of affiliated sites, use of advertising and patient recruitment strategies.
- We are able to lease with health care professionals and primary health care clinics, which ensures effective co-operation in the conduct of clinical trials.
IP storage/dispensing
AddClin Research has the staff, expertise and storage facilities allowing for a secure, temperature and humidity controlled dispensary unit, which enables us to manage investigational supplies according to GCP guidelines and national guidelines. Three staff members have recently completed the dispensing course.
Highest Quality is achieved through:
- Ongoing training, documented in Training Records
- Formal instruction on Standard Operational Procedures
- Ongoing training / refresher courses eg. CPR for clinical staff
- GCP Trained clinical staff
- Internal Quality Control and audit
- A comprehensive set of Standard Operational Procedures (SOP’s) is in operation to ensure that every aspect of clinical research is conducted in accordance with ICH GCP guidelines.
- Favourable sponsor audits and South African MCC inspection.