Medical Affairs Consulting
At Celero, we understand that every client's medical development needs are unique, and we work closely with our clients to develop customized solutions that meet their specific requirements.
Medical Writing Services.
We ensure that all medical writing is clear, concise, and adheres to regulatory guidelines.
Our team of professionals is dedicated to providing exceptional Medical Affairs services to ensure the success of our clients' clinical development programs and to bring their medical products to market efficiently and effectively.
Study Protocol Development
We offer services for the creation, review, and optimization of clinical study protocols. We ensure they are comprehensive and adhere to regulatory guidelines. Our goal is to minimize the risk of protocol deviations and delays, accelerating the initiation of your clinical trial
Informed Consent Form (ICF) Services
We provide clear and concise ICF writing services, complying with both regulatory and ethical requirements. We offer development, review, and optimization of the ICFs, and also provide support for ICF translations and adaptations as needed.
Clinical Study Report
We assist in creating detailed clinical study reports (CSRs) that align with regulatory standards. Our experienced team of medical writers and statisticians is dedicated to delivering accurate and concise CSRs. We understand their importance for regulatory submissions, product approvals, and scientific publications.
Scientific Publication Writing
Scientific Publication Writing: Our team aids in the development of scientific publications such as manuscripts, abstracts, and posters to help disseminate your study results. We ensure these publications meet international guidelines and are ready for submission to scientific journals and conferences
Medical Monitoring Services.
Our medical monitors play a crucial role in maintaining the safety and efficacy of clinical trials.
Medical Monitors oversee and evaluate clinical data, manage the medical aspects of the research, and provide medical advice to the clinical team. They ensure the study adheres to both the protocol and regulatory standards. Furthermore, they supervise clinical trials, assess and approve study-related materials, and guarantee these materials are in compliance with regulatory directives and ready for submission to regulatory bodies.
Safety Monitoring
- Adverse Event Review: Identifying potential safety concerns and recommending necessary actions.
- Safety Signal Detection: Utilizing statistical methods to identify safety signals and concerns.
- Safety Reporting: Preparing accurate and compliant safety reports in collaboration with our medical writers.
- Safety Management Plan: Developing a comprehensive safety management plan, in collaboration with our Medical Writing Team.
Clinical Data Review Services
- Quality Control: Comprehensive data review to ensure its accuracy and consistency.
- Safety Data Review: Identification and analysis of safety signals, adverse events, and serious adverse events.
- Efficacy Data Review: Evaluation of the statistical significance and clinical relevance of the trial results.
- Regulatory Compliance: Ensuring clinical trial data meets the latest regulatory standards.
Medical Oversight and Guidance
- Study Design: Guidance on study design to ensure it is scientifically sound and regulatory compliant.
Protocol Development: Guidance on the development of all aspects of the protocol. - Investigator Selection: Assistance in selecting qualified investigators for your trial.
- Data Review: Review and analysis of trial data to ensure its accuracy and completeness.
- Safety Monitoring: Ongoing safety monitoring including the review of all safety data.
- Regulatory Compliance: Guidance on regulatory compliance throughout your clinical trial.
Biostatistics.
We support the planning, analysis, and interpretation of clinical trials.
We tailor our services to align precisely with the unique requirements of each client. With our expertise, you can be confident that your study is statistically robust, meets all regulatory standards, and that your findings are analyzed and conveyed with accuracy.
Study Design
Our experienced biostatisticians assist with the design of clinical trials, ensuring study designs align with study objectives and regulatory guidelines. This includes services like sample size calculation, randomization, and creation of statistical analysis plans.
Statistical Analysis
We offer comprehensive statistical analysis services, using advanced statistical methods to identify trends and patterns that support the study objectives. These services facilitate the development of clinical study reports and regulatory submissions.
Data Monitoring
Our biostatisticians work closely with the clinical team to monitor data, ensuring the study is conducted in accordance with the protocol and regulatory requirements, thus maintaining safety and effectiveness.
Pharmacokinetic and Pharmacodynamic Analysis
Specialized evaluation services to assist in the creation of clinical pharmacology reports and regulatory documentation. Our experts employ sophisticated modeling and simulation methods to interpret data, pinpointing trends and patterns consistent with the research goals.
Post-Marketing Studies.
Ensuring the Safety and Efficacy of Your Product.
At Celero, our expertise lies in Phase 4 clinical trials. We offer comprehensive assistance, from designing the study and recruiting patients to managing data and conducting statistical evaluations. We leverage the latest technologies and methods to ensure proficient and skillful study implementation.
Key points to note:
- Tailored Approach: Our team crafts and conducts trials tailored to your distinct needs and aspirations, guaranteeing they are in sync with your research aims and regulatory standards.
- Optimal Efficiency: Through the adoption of modern technology and methods, we optimize the study procedure, adeptly handling multi-location and global Phase 4 trials to ensure they conclude on schedule.
- All-Inclusive Offerings: From the initial stages of study design to the final statistical evaluations, our suite of services encompasses every facet. This ensures you attain precise, dependable, and impactful outcomes.
Global Coverage
Celero Executive team have experience in 80 trials across multiple clinical development phases (P1-P4) in more than 25 countries (APAC, LATAM, MEA, Eurasia, EU, Central & Eastern Europe).
Introducing the Celero Way
A pathway to high-quality, cost-controlled, accelerated trials tailored to your needs.
Learn more about The Celero Way or speak to our Medical Affairs expert.
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Speak to an Expert
