SERVICES
USMB RDS endeavours to provide its clients with quality outcomes using the right skill sets, right technology like AI and ML and dedicated service required to manage clinical research studies. As a CRO we embrace your goals as ours and manage your clinical research studies as our own. To help you conduct research which meets the highest standards of quality, we apply a unique toolkit of clinical research professionals, advanced technologies, and decades of global clinical research experience.
Whether you require a full service CRO or a functional outsourcing relationship, USMB RDS welcomes the opportunity to collaborate with you. The clinical research your organization conducts has the potential to deliver life-changing medical advancements. To do so requires dedicated and minutely detailed management of clinical trial safety risks.
At USMB RDS, we understand the importance of patient safety to our clients and the assurance of managing enrolled patients safely through the duration of your study. We aim to provide you with a forward-thinking approach and a coherent safety data plan. Then in collaboration with you and clinical trial sites, we ensure that you effectively capture and analyse safety data, identify data interrelationships, and proactively uncover adverse event trends. Safety issues can vary significantly by disease type and state, requiring expertise across a broad spectrum of therapeutic areas. With experience in Oncology, Cell & Gene Therapy, Hematology, Vaccines & Infectious Diseases, Ophthalmology, Neurology and Substance use, USMB RDS can provide you with the confidence you need to proactively assess and address your unique safety challenges. Our ultimate goal is to ensure that your study is safe for patients and provides the strongest case for your regulatory submissions. To optimize your early development or pivotal clinical research, USMB RDS’ Safety and Pharmacovigilance team, comprising experienced physicians and clinical professionals is here to support you.
We employ AI powered data analytics platforms to ensure that all potential/actual safety events and observations are captured, recorded, reported, analysed individually, precisely and in aggregate. The integration of AI technologies offers significant advantages, including early detection of adverse drug reactions, improved data quality, and faster response times. The most important benefits of AI are reduced cycle times. Due to this method, the processing is spontaneous. Improve the quality and accuracy of the information. AI can handle or manage diverse types of incoming data formats. It can be used for the identification of ADRs. AI is useful to reduce the burden and time of case processing. AI tools extract the information from the adverse drug event form and evaluate the case validity without the workforce.
Medical Safety Services (ICSR)
- Review of Safety monitoring plans
- Real time monitoring of safety data
- SAE Narrative Review and follow-up
- Case reporting for SAEs
- Risk minimization activities/risk management plans
- Event trend analysis and STAR report
- MedDRA and WHO Drug coding
- RMP development
- Therapeutic area and clinical development consulting
- We provide Medical Review of Adverse Events/Serious Adverse Events
- Review and Verification of appropriate sections of adverse events, appropriate MedDRA Coding, seriousness, causality, expectedness Assessment and provide a Medical Assessment Comment as needed for ICSR,
- We Review the Source Documents to assure the information pertaining to the case is accurate and entered into Global Safety Database correctly and verify consistency between source documents and narrative summary.
- We actively follow up the adverse events to obtain more information and review all responses from investigators for queries for appropriateness and completeness, start an ad-hoc follow-up whenever required,
- Actively involved in case discussion with client and provide the valuable inputs to the team and Medical assessment.
- Preparation of STAR report.
Medical Data Review Services (MDR)
- Review of Data listings of adverse events, Medical History, Concomitant medications, Vitals and lab parameters.
- Identification of any discrepancy and inconsistency in reported patient data that requires further investigation with the clinical site to determine overall accuracy.
- Review all inclusion and exclusion criteria to ensure each patient meets minimum level of acceptance into the clinical trial.
- Review investigation product dosing records to determine adherence to protocol and identify possible inaccurate/missed dosages.
- Review all reported Adverse Events (AEs), Concomitant Medication and medical history information to ensure all supporting information is expected and/or implausible data is verified and adherence to protocol expectations and its impact on other patient reported/observed information (e.g., laboratory results, AEs, etc.)
- Ensure end-of-treatment (EOT) and end-of-study (EOS) information is correctly documented to determine primary reason for the patient ending treatment or ending participation in the clinical trial
- Review all laboratory results to ensure completeness of information and adherence to protocol schedule of events and determine if reported laboratory values represent a potential safety condition not reported in the AE information for the patient
- Review any other information as necessary to determine overall readiness of the patient information for next level review
- Prepare Summary report with emphasis on clinically significant outliers
Medical Devices
Medical device development presents unique challenges to companies seeking approval of novel products. Increasingly impacted by regulatory measures, new technologies, and healthcare economics, companies developing new devices require a disciplined approach to succeed. Successful product development paths are often guided by thoughtful regulatory, economic and development strategies, as well as meticulous detail to clinical trial execution. From the first stages of getting your device classified by regulatory authorities through market surveillance on your approved product, our team of experienced professionals can help you mitigate risk by navigating regional or global regulations that apply to your device.
Medical Device Services
USMB RDS offers a variety of global development and commercial services to help advance your medical device from development to commercialization.
- Phase I-IV clinical trial management
- Medical Safety and Medical Data Review services
- Data evaluation and analysis by medical team
- Statistical analysis and reporting