Simona Rizea Savu, Managing Director
The clinical trial management landscape is hard pressed with a plethora of challenges—ranging from adoption of technologies, regulatory requirements, persistent issues in patient recruitment, and spiralling costs. Amid this dynamic industry scenario, Germany-based 3S Pharmacological Consultation & Research (3S Pharma), a CRO that delivers three phases of clinical trial services, is addressing these challenges with grace and a difference. In a complex industry dictated by time-to-market pressures, 3S Pharma doesn’t opt for shortcuts yet abides by industry requirements and short timelines to deliver scientifically-proven, superior quality clinical trial services, with focus on science and safety.
“Despite several challenges persisting in the realm, we haven’t ever picked up the first and easiest solution possible. Instead, we view certain things from a different perspective,” says Simona Rizea Savu, the managing director of 3S Pharma. “We care about our customers, our work, and our subjects, and try to find a unique solution for every specific study.” In order to address the challenges listed above, 3S Pharma maintains an up-to-date database stratified by age, gender, and pathology, builds in-house services to curtail costs, adopts technologies early, and maintains continuous communication with regulators through workshops and conferences.
Since commencing its journey in 1996, 3S Pharma has developed a wide range of CRO & CMO services that not only include clinical studies, but also comprise bioequivalence/ bioavailability studies, pharmacokinetic profiles, drug-drug interactions, adhesion performance, pain assessment studies, taste assessment for oral suspensions, and blanching (VCA) studies, among others. Besides, 3S Pharma’s partial services include site management, clinical monitoring, and external auditing. The organisation also provides bio-analytical services such as LC-MS/ MS, ICP-MS, Lig and binding for small and large molecules such as peptides, proteins, polysaccharides, monoclonal antibodies, and bio-markers. This more than two-decade-old company performs high-quality execution of the clinical studies, as well as, finds the optimal design for a particular study.
A state-of-the-art analytical laboratory, equipped with high-end equipment, including four robotic systems for automatic sample preparation, helps 3S Pharma to carry out these clinical studies and design other CRO & CMO services with further efficiency.
We are also developing a technique that would assess the distribution on the mucosa of the intra-nasal administered products by computer tomography, and we do perfom the assessment of their local tolerability by nasal endoscopy
3S Pharma’s clinical facilities support long-term confinement. The one located in Romania also permits the dosing of large groups of subjects, with the availability of a total number of 74 beds. 3S Pharma’s analytical laboratory efficiently delivers its bio-analytics service using LC-MS/MS machines from SCIEX and Shimadzu. The lab has the capability of analysing over 100,000 samples, yearly.
The technologies leveraged by 3S Pharma exceeds to areas more than just LC-MS/MS techniques, Ligand binding assays, and robotic automation, and include ICP-MS techniques andother highly advanced systems for samples identification (3D coding of samples). For clinical studies, the company makes use of thermal photography, chromameters, ultrasonography, superficial veins detectors, oxygen monitoring, and electric grinder for tablets in both their standard modes as well as in innovative ways.
In fact, the crushing of tablets becomes a necessity at times, but the available procedures are extremely elaborate and time-consuming as they need manual intervention, per Simona. “Hence, we have validated a highly standardised procedure using an electric pill grinder, which is much faster and ensures highly reproducible results,” she explains. 3S Pharma is also using innovativemedical diagnostic technologies like thermal photography for adhesion performance of TDS and highly accurate and automatic adhesion data processing. In the long-acting injectable product section, too, the company has introduced innovation. Since intramuscular products always bear a risk factor if injected in a vein instead of the muscle, 3S Pharma’s injectable products are administered underultrasound control (colour Doppler technology) that eliminates the risk of accidental injection in a vessel. Simona adds, “We are also developing a technique that would assess the distribution on the mucosa of the intra-nasal administered products by computer tomography, and we do perfom the assessment of their local tolerability by nasal endoscopy.”
Ever since its first clinical trial in 1997, 3S Pharma has never lagged in its focus on safe and scientifically-proven solutions, innovative and high-quality services. In the forthcoming days, the organisation wants to sharpen its focus on immunotherapy and value-added medication. “We believe innovation requires a fresh perspective, and challenging of the status quo. We strive to do this on a daily basis by devising new methods to service our customers. We will continue to abide by our motto: ‘We search for solutions, you save time and money, and problems are solved’,” concludes Simona.