- Regulatory Affairs
- Project Management
- Quality Assurance
- Medical Writing
Altiora's experience ensures regulatory compliance, with provision of quality assurance and preparation of documentation for regulatory authorities, including:
- Collation, review and development of CT regulatory documents
- Translation & Validation of relevant CT documents in Local Languages
- Submission to relevant Ethics Committees
- Regulatory application preparation
- SUSARs and ASURs timely submission
- Continuous regional countries legislation review and update.
By definition, project management involves the process of planning, organising, securing and managing resources to achieve the best possible outcome for each study.
Altiora's project management is in charge of the strict implementation of processes, thus ensuring the quality of the project and also maintaining tight budgetary and timeline controls.
We work with our clients as a strategic partner, to deliver successful projects. Your project manager will act as single point of contact, exchanging information on a continuous basis.
Altiora has an established, experienced Safety Unit Team.
By integrating Clinical Research & Post Approval Safety with Medical Devices Safety, we built on our years of experience in Safety Reporting in Clinical Research.
Altiora's Safety Unit Team has a thorough insight of drug safety concerns and corresponding regulatory changes. Our Safety Unit is there to support your Clinical Research, Post-approval & Medical Devices Safety, as below:
- Clinical Trial and Post-approval Case Management
- Literature Search and Reporting
- Local and EU Qualified Person for PV (QPPV)
- Periodic Safety Reporting
We offer high quality clinical monitoring services to manage a trial on time and on budget.
Services include planning, oversight and administration of the clinical sites, following current SOPs, creating strategies and list of activities for site visits.
With a dedicated clinical monitoring team ensuring ICH GCP compliance and data integrity at each site visit, Altiora consistently retrieves high quality, on-time data.
Altiora applies biostatistical models in Clinical Trials, from analysis of data collected and organization of numerical and clinical data obtained from study sites. Our use of statistics assists in the prediction of adverse events.
Our bioinformatics covers Data Mining, Machine Learning and Pattern Recognition, Sequence and Structure Alignment, Gene Finding and Gene Expression Analysis, Protein Structure Prediction, Comparative genomics analysis and Genome-wide functional association studies.
The management of multiple site trials, often with differing regulatory requirements, is achieved efficiently and with cost savings.
Our capabilities include contracted warehousing and distribution of investigational drugs and clinical supplies. These services are often provided as a part of a full clinical services contract, but can also be included on a stand-alone basis.
Our contracted facility has been audited, which in turn helped us continuously improve our services to meet changing sponsor and regulatory requirements.
Altiora offers planned, systematic activities implemented by our quality management system and engages in continuous improvement to Quality manuals, ensuring that regulatory requirements are fulfilled.
Our QA department is autonomous and reports directly to the Clinical Operations Director. We can organize independent reviews and audits of clinical trial investigators sites, research groups and sponsor clinical operations, to ensure compliance with Good Clinical Practice (ICH-GCP) and local regulatory standards, as a part of our clinical trial service offering.
At Altiora we ensure that documents comply with regulatory and SOPs and we create documents effectively and clearly for regulatory documentation.
We ensure elimination of bias in treatment assignment and blinding by using probability theory, specific randomization procedures and adaptive randomization.