A smartER approach to clinical development

Synapmed combines advanced AI technology and intelligent workflow automation with expert scientific talent to drive clinical study and trial success. Our tailored services ensure efficient execution, strict compliance, and reliable data management. By accelerating timelines and minimizing risks, we help you make informed decisions and overcome challenges, helping deliver impactful therapies, faster.

Enhance clinical therapy development with AI-Enabled data-driven operational support

Our full range of clinical service capabilities illustrate how our integration of Real World Data (RWD) and Real World Evidence (RWE)–driven by AI-enhanced platforms–empowers every phase of your clinical trials, from start-up to close-out. With our expert project staffing support, we turn data into actionable

Ensure the integrity and efficiency of your clinical data with our comprehensive management services. We leverage advanced AI and intelligent automation technology, RWD/RWE benchmarking and best practices to support your drug development program.

  • Tailor robust databases to fit your study needs
  • Design and develop intuitive CRF/eCRFs for accurate data collection
  • Maintain high data accuracy with meticulous entry and validation processes
  • Clean data and manage queries to address and resolve inconsistencies
  • Secure your data with reliable locking and long-term archiving

Ensure precise and compliant analysis of your clinical trial data with our expert biostatistics and statistical programming services. We deliver accurate, actionable insights to support your drug development program.

  • Conduct thorough statistical analysis planning and sample size calculations
  • Perform comprehensive statistical analysis and reporting
  • Create clear data visualizations
  • Provide expert statistical programming, including CDISC-compliant data conversion
  • Develop SDTM and ADaM datasets and handle TFL programming
  • Ensure rigorous quality control and validation of all statistical outputs

Achieve success in your clinical trials with our expert project management services. We provide comprehensive support throughout the clinical development process, ensuring that every aspect of your project is effectively managed.

  • Develop detailed project plans tailored to your specific needs and goals
  • Create and manage budgets to ensure cost-effective execution
  • Efficiently allocate resources to optimize project performance
  • Identify and mitigate risks to minimize potential disruptions
  • Track project progress and ensure milestones are met on schedule

Ensure the safety of study participants and the integrity of trial data with our comprehensive Clinical Monitoring services. Our experienced team provides meticulous oversight throughout your drug development process to support successful trials.

  • Identify and evaluate suitable sites for ideal study conditions
  • Assess site readiness and compliance with pre-study visits
  • Start studies with thorough training and setup for full preparation
  • Conduct regular visits to oversee trial progress, data accuracy, and participant safety
  • Finalize site activities and ensure all data is complete and compliant before study closure

Build robust operational teams for your clinical trials with our expert staffing services. 

We specialize in recruiting and placing highly qualified professionals to meet your study’s unique demands, ensuring you have the right talent to drive your clinical trials forward. 

From clinical research coordinators to data managers, our team helps you assemble a skilled workforce that supports every phase of your drug development process.

why synapmed?

At Synapmed, we leverage our deep clinician and data scientist bench and expertise in clinical services to provide tailored services that enhance your development process. We focus on efficiency by quickly identifying and deploying top talent to meet your specific needs, ensuring your clinical trials run smoothly.

Our team is committed to compliance, staying up-to-date with the latest regulations like ICH-GCP, FDA, and EMA guidelines to keep your studies on track. We prioritize exceptional customer service, working closely with you to understand your requirements and providing ongoing support throughout the therapy development process. We aim to deliver high-performing, compliant, responsive clinical services that drive your success.

Services

RWD Analytics & RWE Modeling & HEOR

Leverage real-world data to enhance clinical study and trial design. Our modeling for toxicology, safety, and efficacy profiling uses patient experience data to inform and optimize new therapy development.

Regulatory Affairs

Ensure your clinical studies meet regulatory requirements with our expert team. We provide strategic planning, submission preparation, agency interactions, and compliance support, all customized to your specific needs.

Medical Affairs

Our Medical Affairs services provide clients with an experienced team focused on ensuring product safety and efficacy. Leveraging our expertise in medical and scientific principles, we work closely with clients to develop customized strategies that include medical writing, monitoring, education, and communication.

Pharmacovigilance & Safety

Protect study participants and maintain trial data integrity with our expert pharmacovigilance team. We provide safety reporting, monitoring, signal detection, and risk management, ensuring robust safety management throughout your clinical trials.

Medical Information Call Center (MICC)

Ensure seamless support for clinical trials with our MICC services. We provide expert handling of medical inquiries, adverse events, and trial-related questions, essential for maintaining the integrity and efficiency of your clinical studies.

Technology Implementations

Fuel your initiatives with our cutting-edge technology services, driving innovation and operational excellence.

conneciton

Real World Data (RWD) vs Real World Evidence (RWE)

Real World Data (RWD) and Real World Evidence (RWE) offer significant opportunities and challenges for pharmaceutical companies. RWD, derived from everyday patient product usage through channels such as electronic health records and social media, provides valuable insights into diverse populations, particularly post-marketing. While randomized clinical trial data remains the gold standard, regulators acknowledge RWD’s potential to enhance safety assessments. However, challenges like a lack of standardization in data collection and privacy concerns persist. The FDA addresses these issues through technologies like the My Studies App, which integrates data from various sources to improve patient care and reduce financial risks.

Dedicated to youR Project

No matter the size or scope of your projects, you have a committed partnership team with Synapmed. A team that listens, pays attention to details, and brings smart insights to the table. All so you can solve real problems throughout the product development and commercialization lifecycle.