Clinical Development
Your partner through each phase of clinical development with our comprehensive solutions and execution ability
About Clinical Development
At Synapmed, we understand the challenges that come with building a high-performing clinical development team. That’s why we offer comprehensive Clinical Development Staffing Services designed to help you build an efficient, compliant, and customer-focused team.
Our Technology services
Efficiency
IMP Management
Clinical Project Management
Clinical Safety:
Compliance
Clinical Operations
Clinical Monitoring
Clinical Quality Assurance
Customer Service
Biostatistics
Regulatory Affairs
Clinical Data Management
Statistical Programming
Medical Affairs
Efficiency
We understand the importance of efficiency in the clinical development process. That’s why we work closely with our clients to identify their staffing needs and provide them with the right professionals to get the job done. Our experienced recruiters have deep knowledge of the industry and can quickly identify the best candidates for your team. We also leverage our vast network of industry contacts to identify top talent in a timely manner, ensuring that your team is up and running as quickly as possible.
Compliance
We know that compliance is critical in the clinical development process. Our team of experts is well-versed in all applicable regulations and guidelines, including ICH-GCP, FDA, and EMA guidelines, and we ensure that all of our candidates are fully compliant with these regulations. We also provide ongoing training and support to our staff to ensure that they remain up-to-date on the latest regulations and guidelines.
Customer Service
We believe that customer service is the key to building long-lasting relationships with our clients. That’s why we provide a personalized, responsive, and flexible service to meet our clients’ unique needs. We work closely with our clients to understand their staffing requirements and provide them with the right professionals to meet their needs. We also provide ongoing support and communication throughout the staffing process to ensure that our clients are satisfied with our services.
Overall, our Clinical Development Staffing Services are designed to provide our clients with an efficient, compliant, and customer-focused team. We understand the importance of building a high-performing team in the clinical development process, and we are committed to providing our clients with the best possible staffing solutions. Contact us today to learn more about our services and how we can help you build the team you need to succeed.
Clinical Data Management
At Synapmed, we offer comprehensive Clinical Data Management services to support your drug development program. Our experienced team of professionals is dedicated to ensuring the quality, accuracy, and completeness of your clinical data throughout the entire data management process. We utilize the latest technology and best practices to ensure that your data is managed efficiently and effectively. Our services include:
- Database design and development
- CRF/eCRF design and development
- Data entry and validation
- Data cleaning and query management
- Database lock and archiving
IMP Management
At Synapmed, we understand the critical importance of Investigational Medicinal Product (IMP) management in clinical trials. Our team of experts is experienced in managing all aspects of IMP management, including:
- IMP sourcing and distribution
- Temperature monitoring and control
- IMP accountability and reconciliation
- Deviation management
- Destruction and disposal
We are committed to ensuring that your IMP is managed safely and efficiently, in compliance with all applicable regulations and guidelines.
IMP Management
At Synapmed, we understand the critical importance of Investigational Medicinal Product (IMP) management in clinical trials. Our team of experts is experienced in managing all aspects of IMP management, including:
- IMP sourcing and distribution
- Temperature monitoring and control
- IMP accountability and reconciliation
- Deviation management
- Destruction and disposal
We are committed to ensuring that your IMP is managed safely and efficiently, in compliance with all applicable regulations and guidelines.
Clinical Operations
At Synapmed, we offer a full range of Clinical Operations services to support your clinical trials, from study start-up to close-out. Our team of professionals has extensive experience in managing clinical trials across a wide range of therapeutic areas and phases, and we are committed to providing our clients with the highest quality services. Our services include:
- Site selection and feasibility
- Study start-up activities
- Site management and monitoring
- Data management and monitoring
- Medical monitoring and safety reporting
- Study close-out activities
Biostatistics
At Synapmed, we offer comprehensive Biostatistics services to support your drug development program. Our team of experienced biostatisticians is dedicated to ensuring that your clinical trial data is analyzed accurately and efficiently. We utilize the latest statistical methods and software to provide you with the highest quality analysis and reporting. Our services include:
- Statistical analysis planning
- Sample size and power calculation
- Statistical analysis and reporting
- Data visualization and interpretation
- Independent statistical consulting
Statistical Programming
At Synapmed, we offer expert Statistical Programming services to support your clinical trials. Our team of experienced programmers is dedicated to ensuring that your clinical trial data is analyzed efficiently and accurately. We utilize the latest statistical programming languages and software to provide you with the highest quality programming services. Our services include:
- Statistical analysis programming
- CDISC-compliant data conversion
- SDTM and ADaM programming
- TFL and analysis dataset programming
- Quality control and validation
We are committed to providing our clients with the highest quality programming services, in compliance with all applicable regulations and guidelines.
Clinical Project Management
At Synapmed, we understand that effective project management is critical to the success of clinical trials. Our Clinical Project Management services are designed to provide our clients with an experienced team of professionals who can help ensure the success of their clinical trials. Our project managers are highly skilled and have a deep understanding of the drug development process. They work closely with our clients to understand their specific needs and develop a customized project plan that meets their requirements. Our project management services include project planning, budgeting, resource allocation, risk management, and project monitoring.
Clinical Monitoring
Clinical monitoring is a critical component of the drug development process. Our Clinical Monitoring services are designed to provide our clients with an experienced team of professionals who can help ensure the safety of study participants and the integrity of trial data. Our clinical monitors are highly skilled and have a deep understanding of regulatory requirements and industry standards. They work closely with our clients to develop a monitoring plan that meets their specific needs. Our monitoring services include site selection, pre-study visits, initiation visits, routine monitoring visits, and close-out visits.
Regulatory Affairs
Regulatory affairs is a critical component of the drug development process. Our Regulatory Affairs services are designed to provide our clients with an experienced team of professionals who can help ensure compliance with regulatory requirements and guidelines. Our regulatory affairs professionals have a deep understanding of regulatory requirements and guidelines and work closely with our clients to develop a regulatory strategy that meets their specific needs. Our regulatory affairs services include regulatory strategy development, regulatory submissions, regulatory agency interactions, and regulatory compliance.
Medical Affairs
Medical affairs is a critical component of the drug development process. Our Medical Affairs services are designed to provide our clients with an experienced team of professionals who can help ensure the safety and efficacy of their products. Our medical affairs professionals have a deep understanding of medical and scientific principles and work closely with our clients to develop a medical affairs strategy that meets their specific needs. Our medical affairs services include medical writing, medical monitoring, medical education, and medical communication.
Clinical Safety
Ensuring the safety of study participants is of utmost importance in clinical trials. Our Clinical Safety services are designed to provide our clients with an experienced team of professionals who can help ensure the safety of study participants and the integrity of trial data. Our clinical safety professionals have a deep understanding of safety reporting requirements and work closely with our clients to develop a safety management plan that meets their specific needs. Our safety services include safety reporting, safety monitoring, safety signal detection, and safety risk management.
Clinical Quality Assurance
Ensuring the quality of clinical trial data is critical to the success of drug development programs. Our Clinical Quality Assurance services are designed to provide our clients with an experienced team of professionals who can help ensure the quality of trial data. Our quality assurance professionals have a deep understanding of quality assurance principles and work closely with our clients to develop a quality management plan that meets their specific needs. Our quality assurance services include quality system development, quality audit, and quality control.
Learn more about our Technology services
Let's Get Started
Contact Info
USA-Headquarters
103 Carnegie Center
Suite 300
Princeton
NJ 08540-6235
Global Locations
Bangalore, India
Singapore
Malaysia