Maxime Stevens, Chief Business Development Officer
In its entirety, the process of drug discovery and development can take more than a decade, and is extremely expensive to biotech and pharmaceutical companies. The short patent life on drugs requires the pharmaceutical sector to ensure that these drugs reach the market as soon as possible. The growing regulatory constraints and issues regarding access to patients poses another challenge. Evidently, speeding up the time to market is an imperative facet within drug development. In this scenario, OPTIMAPHARM steps in with a team of professionals who understand how to navigate the regulatory, logistical and cultural challenges of performing studies in a number of different countries. A full service CRO, OPTIMAPHARM has a high-level expertise in managing trials across Europe. “Eastern Europe and Southern Eastern Europe are excellent places to perform clinical trials, as there is an unrivalled access to high quality investigators willing to participate in trials, who want to help their patients with unmet medical needs and access to drugs,” says Igor Čičak, co-founder and president of supervisory board, OPTIMAPHARM. This makes the region excellent for patient recruitment and is extremely cost efficient. Trials can be delivered faster therefore expediting drugs along the development continuum and speeding up market access.
OPTIMAPHARM’s in-depth understanding of the regions where it operationalizes gives it a unique understanding of specific requirements to deliver studies faster. With offices in 12 countries in Western, Central and Eastern Europe, as well as a network of preferred partners, OPTIMAPHARM ensures the recruitment of large numbers of patients on time and within budget to minimize problems stemming from patient access in the region. OPTIMAPHARM’s regulatory team understands the nuances and complexities of each country’s system, and is able to expedite the start-up of clinical projects across Europe while accessing dynamic recruitment regions across the continent.
We understand the nuances of study set up, regulatory, patient access, and study delivery across our countries
Country-based regulatory specialists and experienced country managers help OPTIMAPHARM to provide its customers with regulatory advice in developing its local or regional strategy, and reviews and updates the same as required. The company’s monitors use a pragmatic yet disciplined approach to support investigators and nursing teams on their sites. Certified project managers experienced in managing cross-functional teams ensure that the key performance indicators and milestones are met during trials. The company proffers project planning, tracking and reporting, together with proactive risk and mitigation strategies.
Data management, another major requirement for many companies, is catered by OPTIMAPHARM. The company provides inputs on protocol design and aids in designing the database and case report form. Similarly, it helps with biostatistics by advising on study design, sample size, analysis plan, statistical analysis and the like. Besides providing assistance with medical writing, OPTIMAPHARM also aids its clients with safety and pharmacovigilance.
The strength of the company stems from its career pathway and culture of teamwork that focuses on high performance— these factors aid in maintaining a low staff turnover of five percent. “Clients can be rest assured that their project teams will not disappear during the study,” says Gordana Gregurić Čičak, co-founder and CEO of OPTIMAPHARM. From a medical perspective, OPTIMAPHARM has considerable experience in performing oncology, psychiatry, cardiovascular, metabolic and respiratory studies, as well as studies in challenging patient populations like adolescent, pediatric or orphan indications.
The organic growth of OPTIMAPHARM proceeded steadily during the first half of 2018, and the company opened offices in the UK and the U.S. The company foresees that new technologies will aid in mid- to long-term clinical research, like drawing focus on wearables and the performance of studies in the community. “With patient groups having a greater say in their treatment pathways and access to medicines, we are constantly working with clients to help them expedite their drug development by utilizing best practices and the right technologies,” Igor concludes.