Who We Are
Founded in 2012, Clindata is a Contract Research Organization (CRO) with offices in South Africa, Sri Lanka and Mauritius. The Clindata core team of experienced, dedicated staff has worked for CROs in the animal health industry for many years.
Clindata brings a wealth of Data Management, Biostatistics, and SAS® experience and prides itself on its streamlined and compliant SOPs.
The teams gained significant experience working on more than a thousand studies across various therapeutic areas, animal species, and regulatory targets (such as VMD, CVMP (EMA), CVM (FDA), CVB (USDA), EPA, EFSA, and others).
Furthermore, all team members are trained in Good Clinical Practice (GCP) and Good Laboratory Practice (GLP).
Processes Aligned to Client Needs
for Compliant,
Fit-for-Purpose Deliverables
At Clindata, our processes are meticulously aligned with client requirements to ensure that every deliverable is of the highest quality, compliant, and fit for its intended purpose. We work closely with our clients to tailor our Data Management and Statistical services, ensuring that the final outputs meet their specific research goals and regulatory standards
How We Work
Clindata is part of the Clinglobal group. Clinglobal provides Clindata with a platform of support services and offers contract management, product development, regulatory affairs, and quality assurance services to Clindata’s customers.
The Clinglobal group organizational model ensures scalability and economies of scale, allowing the resources of each partner company to be assigned by function and focusing on key competencies.
Ready To Work With Us? Get In Touch
Services
Data Management
Data Management Consulting:
Support study planning to ensure the client remains efficient and competitive. Data is a valuable asset, and with correct planning and analysis, Clindata can maximize the information derived from it.
Data Capture Form Design & Review:
Create forms to ensure data entry is streamlined as much as possible for both paper and EDC studies.
Database Design, Build, and Validation:
Databases are built by Clindata programmers using the study protocol as a guide to developing query specifications, roles, and schedule specifications. The Data Team Lead coordinates the validation effort and prepares the Validation Plan, which includes predefined test scripts for verification, as well as internal and external user acceptance testing. The Data Team Lead also compiles the Validation Report.
Database Change Management:
Database feasibility checks and maintenance to ensure it remains compliant and validated.
Data Entry & Tracking:
The raw data is tracked to ensure all observations have been received and entered. Study data entry could involve a single entry with 100% Quality Control (QC), a double entry with 100% QC of the critical datasets and 100% QC on a random 10% of the remaining datasets, or according to a customized sponsor’s request.
Data Reconciliation:
Laboratory data can be reconciled with the source data by the EDC system or manually using Clindata analysis tools.
Study Status Reports and Data Verification (Manual & Automated Edit Checks):
Data cleaning/review consists of using query checks, with queries generated automatically in the system or manually created by the Data Team Lead. A query report comprised of a query summary and missing forms/data will be generated by the Data Team Lead and made available to the study team.
Medical Dictionary Coding:
Dictionary coding or review can be arranged for Adverse Events and Concomitant Medications (or any other dictionary available).
Computer System Validation (CSV):
Clindata’s experienced team performed Computer system validation on all software used or programmed by the Clinglobal group. Ensuring the quality of computer systems and the performance and compliance of electronic data capturing and handling software is critical to data integrity and quality.
Software:
Biostatistics
- Statistical Consulting: Clindata consultants liaise with clients to ensure the project plan is robust and delivers sound statistical analysis. They also provide statistical training, advice, and support.
- Statistical Input into Protocol
- Generation of Randomization Schedules
- Analysis of PK/PD (Parameter Estimation & Modelling)
- Development of SAP & Output Shells
- Statistical Support for Abstracts and Publications
- Statistical Input into the CSR
Software:
Statistical Programming
Clindata programmers create core analysis datasets to serve as central datasets for the raw data and analyzable variables. These are derived from the raw datasets using the specifications and double-programmed by the programming team. The derived analysis datasets are used as sources to produce the statistical summaries such as tables, listings, and figures.
Clindata provides clients with a description of the electronic data files submitted and data processing procedures used to create the statistical outputs of the study in a format accepted by the regulatory authorities. The process is summarized in a ReadMe file and encryption keys for all files submitted.
Software:
Delivery Models
Project-Based Delivery Model:
Clindata is contracted for a specific project or study where the scope, timeline, and deliverables are clearly defined. We manage all aspects of the project, including resources and execution, from start to finish. This model is ideal for clients needing expertise for one-off studies or specific research phases.
Dedicated Resources Delivery Model:
Clindata provides dedicated personnel who work exclusively on a specific client’s projects. These resources act as an extension of the client’s in-house team, allowing for greater control and alignment with the client’s processes and goals. This model is suitable for clients with ongoing needs, requiring consistent support across multiple projects or phases.
Functional Service Provider (FSP) Delivery Model:
In the FSP model, Clindata offers specialized services such as Data Management and Statistical Programming rather than managing an entire project. Clindata functions as a partner, delivering specific functions or the full scope across multiple studies or programs. This model provides flexibility, scalability, and enables clients to maintain oversight of their broader program while outsourcing specific tasks.
Meet The Team
Jaco Kasselman, BTech
VICE PRESIDENT
With 21 years of experience in the Contract Research Organization (CRO) industry, Jaco has in-depth expertise across both human and animal health sectors. He spent 11 years focusing on human health and another 10 years dedicated to animal health at Clindata. Jaco oversees all Data Science operations, including Data Management and Biostatistics.
Lanie Pretorius, BSc Hons
DEPUTY DIRECTOR: DATA OPERATIONS
With 12 years of experience in the Animal Health industry and as a Certified Clinical Data Manager (CCDM), Lanie leads the Data Operations division. She oversees a team of Clinical Data Coordinators, specializing in both EDC and paper-based studies. Her role covers all aspects of study management, from initiation to database locking and archiving. Lanie is also responsible for project management, resource allocation, timeline tracking, and onboarding new clients to the Data Management process.
Roland Klopper, MSc
DEPUTY DIRECTOR: ANALYSIS OPERATIONS
With 18 years of experience as a biostatistician in both human and animal health, Roland oversees statistical programming, biostatistics, and regulatory submissions across Phase I-IV trials. His expertise includes missing data imputation, advanced data analysis (such as MMRM, survival analysis, and generalized linear models), and ensuring the accuracy and compliance of submissions to regulatory authorities. He also has extensive experience working with Data Monitoring Committees (DMCs).
Heleen Sonnekus, BTech
SENIOR MANAGER: DATA OPERATIONS
With 14 years of experience in the CRO industry, covering both Human and Animal Health Heleen’s expertise spans the full scope of Clinical Data Management activities. She is also responsible for leading paper projects, managing timelines, resource allocation, creating cost outlines, onboarding clients, and mentoring clinical data coordinators.
Ruan Rautenbach, BCom
MANAGER: DATABASE PROGRAMMING
With 7 years of experience in the animal health industry, including data management and database programming, Ruan leads Clindata’s database programming team. He oversees the onboarding of EDC systems, manages computer system software validation for these systems, ensures software meets study requirements, and handles sponsor onboarding. Ruan also manages audit trail reviews and contributes to creating data packages for submissions to regulatory authorities.
Heidi Verster, BSc
MANAGER: CLINICAL DATA COORDINATION
With 7 years of experience in Data Management within the Animal Health industry, Heidi manages lab and field projects in EDC. She is responsible for leading projects, overseeing timelines, resource allocation, creating cost outlines, onboarding clients, and mentoring clinical data coordinators.
