Cromos^TM Pharma
"No Patient No Payment" Approach towards Successful Clinical Trials

The pharmaceutical sector is challenged by a series of issues pertaining to clinical trials—patient recruitment, ensuring the safety of human subjects, maintaining consistency and reliability in data, and reducing costs. Additionally, it is commonly observed that trial progressions don’t coincide with the projections made by the CROs, and hence, sponsors lose potential future revenues. Empowering pharmaceutical firms to effectively address these challenges and navigate the changing landscape of clinical trials is US-based CRO Cromos™ Pharma. The company provides its clients with quintessential services that help them reduce costs, shorten timelines, and lower rates of audit findings.

Founded in 2004 by Dr Vlad Bogin, the company has vast international capabilities and offers services that comprehensively cover the requirements of clinical trials in Central and Eastern Europe and in the US. Cromos Pharma has longstanding experience in clinical development strategies, analyses of local standards of care, regulatory compliance, pharmacovigilance and safety support, as well as quality assurance and biostatistics services. Additionally, the company has expertise in medical writing, project and data management, innovative, generics and biosimilar global studies, clinical monitoring, logistics, and site contracting. Cromos Pharma is synonymous with high quality, and its quality management system is geared around the concept of quality by design in combination with real-time risk management.

Cromos Pharma exercises a multi-layer approach towards quality assurance, where it identifies the specific threats and predicts potential recurring risks that might arise during a clinical trial. Considering that every clinical trial is unique, the company’s continuous risk monitoring is the lynchpin of its success. Cromos Pharma constantly assesses and monitors for threats throughout the trial, and it often doesn’t budget them into its proposals. “It is the constant reevaluation that really enables us to find the weak links within a clinical trial. Rather than being reactive to problems, we remain proactive and prevent problems before they can occur,” says Dr. Vlad Bogin, Cromos Pharma’s founder, and CEO.

Cromos Pharma upholds its commitment to ensuring the success of a clinical trial with its “No Patients - No Payment” risk-sharing initiative. While determining or suggesting trial venues, Cromos Pharma discusses the requirements of the clinical trials with the sponsors and assesses the technical capabilities of various locations and the specific procedures they cater to.

The company simultaneously executes risk assessment programs and practices a strong visibility process by remaining upfront about potential difficulties.It then prepares a customized proposal and provides an anticipated rate of patient recruitment for the trial. If the sponsor agrees with the proposal, Cromos Pharma memorializes the recruitment projections in the MSA, and if it underdelivers, it is penalized financially—a scenario unheard of in the industry, which consolidates Cromos Pharma’s claims regarding quality assurance and management. Owing to the presence of large, specialized centers dealing with specific diseases, the company swiftly recruits patients without compromising the quality of data. “Some sponsors are still unaware that our data is FDA, EMA, ICH GCP compliant and admissible, and on par, if not of higher quality than in Western Europe and in North America. But for those who know, it’s one of the prime factors that attracts sponsors to partner with us,” continues Vlad. The company’s teams of seasoned and motivated experts, investigators, and agents forge strong bonds with its sponsors and become their partners to ensure efficient implementation of quality assurance protocols and seamless execution of the trials.

With clinical trials becoming more personalized, biomarker-driven, and targeting rare indications, finding the right patients becomes increasingly arduous. Cromos Pharma is meeting this challenge head-on with its carefully curated referral site program. The company has created a database of competent and robust sites that have a high patient throughput. The company collaborates with the medical professionals at such sites, informs them regarding upcoming clinical trials, and signs referral agreements when there is a fit. Relevant patients are then screened and directed to the trial sites. To illustrate the program better, Vlad cites a recent trial that Cromos Pharma conducted in the US and Central and Eastern Europe. The trial was for hematologic cancer patients, an exceptionally complicated subgroup. Knowing that patient recruitment will be a challenge, Cromos Pharma set up a network of referral sites ahead of time, which enabled it to recruit over eighty percent of the patients within three months. During the Covid-19 pandemic, the company conducted several clinical trials and scripted similar success stories.

Looking ahead, Cromos Pharma aims at establishing a more formidable presence in other regions and expanding its capabilities regarding digitalization and virtual clinical trials. “Our growth has been rather exponential, and we are now strengthening all the aspects of our programs. The goal is to become a comprehensive turnkey partner for small and mid-sized pharmaceutical and biotech companies,” concludes Vlad.