Dr. John Moller, CEO
According to a recent report from the Tufts Center for the Study of Drug Development.
China, India, and South Korea are emerging as key markets for global clinical research and development. Additionally, Asia Pacific became the fastest growing region for biotech-sponsored clinical trials in 2018 with a 35 percent increase in growth rate compared with the previous year. The significant patient population, lower trial density and the rising contribution of Asia to the world’s health innovation contribute to this massive shift. As more biopharma companies look to outsource their clinical development, they are wanting to partner with CROs (Clinical Research Organizations) that uphold a strict code of conduct, quality, and expedited delivery of services. Meanwhile, the size, complexity, duration, and cost of clinical trials continue to rise due to increasing demands. However, Novotech, an independent and full-service CRO, stands out with an international reputation for delivering successful phase I-IV clinical trials in the Asia Pacific region. “Our customers value our leadership as a regional CRO specialist which can understand and manage local cultures, customs, and regulations, and has developed deep relationships with the key investigators in the region.,” says Dr. John Moller, CEO at Novotech.
Biotech companies are increasingly taking advantage of the Australian market to run their first-in-human trials and then move to sites in Asia to accelerate the other phases of their development programs. However, despite the numerous benefits gained by running clinical trials in Asia, sponsors still face the risks posed by fragmented markets, heterogeneous regulatory pathways, as well as differences in standards of care and cultural. This has reinforced the need for them to partner with a regional specialist CRO with a profound understanding of the market nuances. Physical presence in the region is also vital for delivering services effectively.
When it comes to small and medium-sized biotech companies, a major challenge is running the trials at an early phase in an environment promoting simple and predictable regulatory pathways. Alongside, the planning for research at later stages has to be completed under stringent time frames.
To begin with, Novotech is a full-service CRO that helps biopharma companies in building their drug development plan and clinical development. In addition to accelerating clinical development programs by providing project management and clinical trial monitoring, the firm offers an accurate and quality driven biostatistics service. This includes statistical planning and the services of experienced biostatisticians and statistical programmers. Data management is vital for success and the company leverages leading industry tools including Medidata RAVE and ClinTrial, thereby ensuring successful delivery of clinical trial data. In order to mitigate the predicaments in the process involving trial approvals, Novotech has a dedicated regulatory and ethics team who help the clients expedite drug development in a complex and dynamic environment. Novotech has an extensive experience providing regulatory affairs services making the preparation of applications for IECs/IRBs a rapid and professional process. Quality assurance is yet another critical area where their expertise is widely sought. In this regard, their independent quality assurance service across all clinical phases is one of their principal value propositions. Above all, the firm’s handpicked medical writers offer credible scientific content required for the development.
The company has made a significant investment in improving its technology assets. Implementing Oracle’s Trial Management system was one such step they took toward ensuring the delivery of robust yet bespoke services. Further strengthening the company’s presence in Australia, Novotech has acquired Clinical Network Services (CNS) last year. This allows them to offer “BioDesk”, a capability that provides early-stage product development advice including toxicology, CMC and FDA/ EMA regulatory consulting. Novotech invests heavily in building formal partnerships with major hospital and medical specialist sites. It now has 19 formal site partnership agreements, as well as site management services which facilitate rapid startup activities and patient recruitment to meet the sponsor’s goals. The company’s employee strength has grown by more than 20% in Asia over the last quarter of 2018. Fueled by the demand for a regional CRO with international accreditation and reputation, Novotech is growing rapidly to accommodate the demand for local knowledge, partnerships, and expertise.