- Our approach
Our approach is tailored to local circumstances: we act local, but we think global. Regulatory procedures can appear highly fragmented to the untrained eye, and thus difficult to navigate effectively. At Altiora we adopt a proactive approach by establishing and maintaining a strong, purposeful dialogue with the regulatory authorities.Through years of interaction and experience, we have learned how to successfully traverse the complex system, and our knowledge has enabled us to optimize the regulatory approval timeline. Our many and constructive interactions with the regulatory authorities have allowed us to develop first class procedures and processes. These processes allow us to safeguard compliance with AE reporting procedures, ensure timely importation & consistent availability of drug/clinical supplies.
Altiora's quality processes, that ensure we traverse the regulatory hurdles, are very important, but little can be achieved without capable and committed investigators. At Altiora we understand the need to identify investigators and sites capable of the timely enrolment of suitable patients, in sufficient numbers and in full compliance of international and local regulatory standards on GCP. Consequently, we have developed a network of clinicians across a broad range of medical fields and disease areas. Also, Altiora realized it had to operate as an entrepreneurial, market-driven firm. In order to optimize performance and add maximal value to clients, we focus on customers' needs and are agile, without compromising on quality.
Finally, Altiora maximizes the value of its human capital. We fill CRA positions with medical doctors and nurses - highly educated healthcare professionals, with medical backgrounds and know-how, which enable them to establish and maintain solid relationships with other key stakeholders. Stakeholders such as regional opinion leaders, principal investigators and study staff. Our strong relationships with study staff have resulted in consistent adherence to study schedules and protocols, which in turn significantly reduces protocol violations and screening failures. It also reduces study drop-out rates.
In summary, Good Systems + Good People = Good Results
Altiora also provides intensive training to its staff and closely supervises new employees, to ensure that performance levels in areas such as quality, customer-service and results remain high. As a result, Altiora has been able to reduce the clinical trial timeline achieved by other CROs operating in the same region. We are a small, entrepreneurial firm that is committed to customer service and quality, with the agility to be flexible and fast. However, we can also match the capabilities and performance levels of larger companies, while being more cost-effective, due to our lower cost structure. Our low cost structure allows us to meet regulatory standards on GCP for documentation, without being unnecessarily bureaucratic. The entrepreneurial spirit, customer service, cost-effectiveness and agility of a small firm, coupled with the knowledge, experience, quality and performance of a large firm! An unbeatable combination!
We realised that for further growth, it was essential to broaden the scope of our region and services. To do this quickly, while preserving our high quality standards, we work with partners that employ the same customer-driven culture, agility, quality, performance and service capabilities, and who are also able to add value to achieve our ultimate goal - to become competitive on a bigger scale.