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Clinical Monitoring

At Biotrial, we offer a comprehensive clinical monitoring service that is tailored to the specific needs of each trial. We have a team of experienced clinical monitors who are experts in all aspects of clinical trials, from protocol development to data analysis. We also have a global network of Clinical research associates (CRAs) who will provide remote or on-site monitoring support.

We approach clinical monitoring with a sponsor-centric approach, which means that we work closely with sponsors to understand their specific needs and requirements. We are also flexible and adaptable, and we can tailor our monitoring services to meet the changing needs of the trial.

We approach clinical monitoring with a sponsor-centric approach, which means that we work closely with sponsors to understand their specific needs and requirements. We are also flexible and adaptable, and we can tailor our monitoring services to meet the changing needs of the trial.

Our clinical monitoring services include:

Protocol monitoring
Data monitoring
Patient safety
Regulatory compliance
Investigator training
Issue resolution

CRA Expertise

Our clinical research associates (CRAs) are experts in all aspects of clinical trials, from protocol development to data analysis. They are also highly skilled in using eClinical tools, such as electronic case report forms (eCRFs) and clinical trial management systems (CTMS). This allows them to efficiently manage trial data and monitor progress across diverse therapeutic areas, including oncology.

Our CRAs are also extensively trained in ICH-GCP and regulatory practices. This ensures that they adhere meticulously to standard operating procedures (SOPs) and sponsor-specific requirements. They provide guidance and support throughout the study, helping to ensure its success.

biotrial-clinical-patient-trial-management

Remote

Remote medical monitoring is a cost-effective and efficient way to ensure the quality and safety of clinical trials. It allows monitors to stay in constant contact with study sites, without having to visit each site in person, saving time and money.

Biotrial’s remote monitoring services include:

Reviewing clinical trial documentation
Conducting site visits
Monitoring patient safety
Ensuring data quality
Communicating with sponsors and sites

RISK-BASED

Risk-based monitoring (RBM) is a systematic approach to clinical trial monitoring that focuses on the areas of greatest risk. It is a more efficient and effective way to monitor clinical trials than traditional methods, such as full site visits.

Biotrial performs a detailed risk analysis for each clinical trial protocol to determine the different levels of key data and site risk. This allows us to design tools within electronic data capture (EDC) to enable a targeted source data verification (TSDV) or RBM approach to trial monitoring.

Benefits of RBM:

Increased efficiency
Improved accuracy
Enhanced patient safety
Increased compliance

Multicentric

We have a global network of clinical research associates (CRAs) who can perform monitoring visits in many countries in Europe and around the world. This allows us to provide our clients with the flexibility and support they need to conduct multicentric trials.

We are committed to providing our clients with the highest quality clinical monitoring services, regardless of the location of the trial. We believe that our global network of CRAs gives us a competitive advantage in the multicentric trial market.

On-Site Phase I Trials

Our on-site phase I trials offer several advantages

Speed

Our experienced CRAs are fully dedicated to each clinical study and report directly to sponsors. This can save time and improve efficiency.

Quality

Our CRAs are highly skilled and experienced in conducting on-site phase I trials. This ensures that the trials are conducted to the highest standards.

Cost-effectiveness:

Our on-site phase I trials are cost-effective, as we can leverage our global network of clinical research associates (CRAs).

Flexibility

We offer a flexible approach to on-site phase I trials, which can be tailored to the specific needs of each sponsor.

Added values

In-house or local CRAs: We can provide you with in-house or local CRAs, depending on the location of the trial, providing the best possible support for your trial, regardless of where it is located.
Worldwide coverage: We have a well-equipped global network of CRAs who can support your trials in any country in the world.
Flexible to sponsor’s requirements: As a mid-sized CRO, we can tailor our services to meet the specific needs of each sponsor.
Qualified and experienced staff using the latest technology: Our staff is highly skilled and experienced in all aspects of clinical trial monitoring, including the latest technology and software.
CRAs trained to ICH GCP E6 R2, GDPR/HIPAA: Our CRAs are trained to the highest standards, including ICH GCP E6 R2, GDPR/HIPAA. This ensures that your trials are conducted to the highest ethical and regulatory standards.
Broad experience in different therapeutic areas, including oncology: Ensures we can provide you with the expertise you need to conduct your trials successfully.
Extensive experience in Phase I studies performed in our independent CPUs: This gives us a unique understanding of the challenges of Phase I studies and allows us to provide you with the best possible support for your trials.