Over 30 years of global experience enables us to effectively design and execute studies and meet the needs of small and emerging biopharma sponsors by guiding them from strategy to approval in complex indications and modalities across a variety of therapeutic areas.
Globally, CATO SMS successfully conducted over 500 clinical trials ranging from Phase I to IV in numerous indications and patient populations, with oncology representing the majority. Together, these studies enrolled over 60,000 patients worldwide at over 5,500 sites. We have contributed to the successful development of more than 50 marketed products, representing an impressive 10% of all drugs approved by the FDA and EMA in recent years.
As your partner from strategy to approval, we provide clinical trial services all the way from design, setup, and full conduct to closure of Phase I to IV studies.
CATO SMS takes pride in building long-term relationships in which our clients can rely on our expertise and proactive, responsive, and pragmatic approach. We offer a flexible and tailor-made approach to the specific needs of every project, either as a full-service solution or by providing the following stand-alone services to our clients:
Our teams are continuously working with our clinical trial sponsors to find creative ways to improve both the speed and efficiency of their clinical development programs. We take a risk-based approach to assessing protocol design and complete a critical review of the data collection measures, volume and method, patient pathway, and expected outcomes. We strive for an optimized quality delivery according to your timeline, and will bring for discussion alternative strategies that came up while reviewing the landscape for a protocol and have the potential to decrease the likelihood of future protocol amendments. Protocol optimization is available as a consulting service or can be requested as part of your overall regulatory or clinical trial execution strategy.
The global clinical research environment is rapidly evolving, making it essential to explore a digital strategy for remote engagement and data collection for all protocols. We will review the key elements of your protocol such as endpoint data collection methods, schedule of events, vendor data requirements, patient burden, engagement, and retention. As part of this evaluation, our team will consider options for decentralized or hybrid design elements and make a recommendation to help guide you in making decisions that will enhance the delivery of your clinical trial.
We understand the challenges and importance of a successful patient recruitment program. We take a proactive approach to develop a strategic enrollment plan that is patient centric, data driven, and site specific. Our dedicated teams build strong relationships with study sites while utilizing a variety of databases to locate the optimal sites that are best suited to efficiently achieve fast patient recruitment for your specific protocol. Combined with a passion for engaging patients as study partners, we empower sites through education and training to enroll the right patients into your study in the shortest time possible.
Study startup is one of the key cost drivers in your program and requires strong management of critical, time-sensitive deliverables. Experienced decision-making in the areas of study site selection, required essential document collection, and investigator contract negotiations can make or break your timeline. CATO SMS has a dedicated team of study startup specialists including contract and budget experts to make sure your study launches on time and enrolls as quickly as possible.
Our feasibility assessment team will collect and summarize valuable, detailed feedback from clinical research sites to support critical decision-making in your clinical development program. We will help determine important parameters such as patient enrollment rates, most favorable countries, optimal number and distribution of sites needed, local standard of care, viable patient assessments, potential study challenges, competitive trial landscape, protocol review, and investigator grants. We collect the specific site feedback needed to make your study a success, all of which are summarized in a feasibility report with key recommendations to guide your study planning.
To ensure that your study is executed on time and with the high quality expected by regulatory agencies, our project managers will partner with you every step of the way. We will map out operational objectives and identify mitigations for potential risks that are likely to have direct and significant impact on the time, quality, cost, and outcome of your program. Using best practices, our project managers will lead your dedicated project team and ensure that your trial remains well planned and executed throughout the project life cycle.
Key focus areas include:
- Efficient study startup
- Strategic patient recruitment
- High-quality delivery of trial operations
- Collaborative, risk-based decision-making and documentation
- Strong clinical research associate (CRA) leadership and oversight
Our experienced CRAs are an extension of your team. They work effectively with sites — on-site or remotely — to ensure that our patient recruitment and study execution goals are met. CATO SMS’ clinical monitoring services include traditional, full-service monitoring as well as risk-based and centralized monitoring services, depending upon your goals and the needs of your project. Both office-based and regional CRAs are available for assignment according to your preference and your project needs.
CATO SMS dedicated data management professionals know how to tailor the right data plan even for the most unique and complex designs. We will ensure your project has the most effective, efficient, and quality data to cater your specific goals and needs. Our team will guide you through the process, provide advice, and make sure your data will meet the regulatory agencies’ requirements. They work closely with our biostatisticians to ensure that there is a clean, efficient workflow from collection of data through analysis and reporting of results.
CATO SMS provides the full range of statistical services from the development of the statistical analysis plan all the way through to delivery of analysis and table listings and figures to support integrated clinical and statistical reports.
CATO SMS’ medical experts and drug safety specialists are passionate and cognizant of the critical role they play in support of our clients’ development of innovative therapeutics, from conceptualization to product approval and beyond, supporting post-marketing activities and commitments.
We provide our clients with a team of experienced medical monitors for the successful delivery of development programs. Our skilled physicians and health care professionals are an integral part of project teams supporting the successful design and execution of patient-centric programs, always with the best interests of study participants in mind. In addition, they provide:
- Knowledge and experience in a wide variety of indications and therapeutic areas
- Medical advice to sponsors, project teams, and study sites to facilitate discussion and decision making on any medical aspects of the trial in a timely fashion
- Study optimization strategies, including patient recruitment approaches
- Access to medical knowledge and training of project teams on the medical aspects of the clinical research and the indication
- 24/7 medical coverage for eligibility assessment, emergency un-blinding, and/or general study support
- Communication and collaboration with our clients’ counterparts, investigators, and external experts
- Medical monitoring and thorough data review to ensure clinical data integrity
- Oversight over the safety of study participants in collaboration with our pharmacovigilance group
- Medical review of adverse events, safety listings, and interim/final trial reports
- Participation at dose escalation meetings, Data Monitoring Committee/Data Safety Monitoring Board and Clinical Event Adjudication committees
- Identification of any study risks and appropriate mitigation strategies
Patient safety is one of the most important components of drug development. Identifying the safety profile and assessing risk/benefit of a new compound in a timely and responsible manner contribute to the protection of patients’ and public health. Complying with the quickly evolving legal requirements for pharmacovigilance is essential.
CATO SMS’ safety specialists have intimate knowledge of regulatory requirements across geographies and provide a broad spectrum of high standard pharmacovigilance services, using fully validated 21-CFR part 11 and E2B compliant safety database systems to collect, analyze, and report safety information.
Our safety experts provide the following services:
- Optimize the design of safety-related eCRFs and protocol sections
- Function as the Responsible Person (RP) for EudraVigilance (EU) and Regulatory Contact (U.S.), if required
- Triage and process incoming serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs)
- Narrative writing and issue queries as needed
- Preparation of CIOMS and Medwatch forms
- Global expedited case reporting (EU and U.S.)
- Aggregate report preparation and reporting (e.g., DSUR, semiannual line listings)
- Monthly compliance and status reporting
- SAE reconciliation
- Unblinding services
- Global safety database setup and maintenance
- Registering sponsors with EudraVigilance*
- XEVMPD entry and maintenance*
* Please note CATO SMS pharmacovigilance managers are certified by EMA as EVWEB and XEVMPD users in the EudraVigilance system
CATO SMS is experienced in performing oversight services on behalf of international pharmaceutical companies for trials that extend across Europe, North America, and Latin America. Use of highly experienced monitoring personnel, coupled with quality driven assessment protocols, ensures that the needs and expectations of both the sponsor and regulators are met and that the trial and data generated meet the desired quality.