Our full suite of medical consulting services includes protocol development and review to ensure sensible design and appropriate patient safety, case report form review, interaction with safety and advisory committees, statistical analysis review, and analysis of trends or clinically significant events. Our physicians can serve as a medical liaison to any member of the investigative team. Please contact us to discuss your medical consulting needs.
Drug Safety Solutions’ team of physicians is accessible to investigators, team members, and sponsors 24 hours a day via cellular phone or email. We assign one physician to each study as the “primary team member,” and a second physician, who is also fully familiar with all aspects of your project, to assist you when the primary physician is not available.
Our physicians fully monitor and participate in all phases of each project, including interactions with investigative sites regarding protocol interpretation, inclusion and exclusion criteria for patients, assessment and management of medical and laboratory data, and noted safety issues that arise during the course of a clinical trial. This service is available to investigators and the study team 24 hours a day.
Serious Adverse Event (SAE) Management
We offer full SAE management—and ensure strict adherence to all related regulatory guidelines in clinical trials and for postmarketing. Our drug safety personnel have handled SAE management at all phases of clinical trials, and have worked on trials of various sizes, including megatrials with over 1,100 reported SAEs. They have worked in a variety of therapeutic areas, and have first-hand experience entering safety information into sponsors’ databases.
We offer full SAE management and ensure strict adherence to all related regulatory guidelines. Our drug safety personnel collect the required data, prepare the serious adverse event narratives, provide sponsor comment, reconcile adverse event and serious adverse event databases, and monitor trends within a protocol or subject population. We work closely with your company’s medical group to assess your needs and ultimately bring you the product you require, in the style that best fits your company.
Coding and Safety Reviews
Drug Safety Solutions’ medical team will review coding reports to ensure that each term is coded properly and consistently throughout the study. The team will also review adverse event listings, SAE listings, concomitant medications, procedures, laboratory results, and physical findings to ensure that all safety data is captured appropriately and to review for signals or trends.
Literature Search, Review and Assessment
Our literature search team will determine parameters for literature esearches by working closely with each client and then program the searches to verify that the highest quality data is provided. The medical team will review all findings to determine the relevancy of each finding and if appropriate, report these and provide medical assessments for the case.
Data Safety Monitoring Boards (DSMB) Management and Participation
Drug Safety Solutions will provide management of a DSMB to include recruiting and contracting members, creating charters, organizing and running all meetings, capturing all meeting details and providing assessments from the DSMB. In addition, Drug Safety Solutions can also provide physicians as needed to other DSMBs.
Safety Monitoring Committee (SMC) Management and Participation
Drug Safety Solutions will provide management of a SMC to include recruiting and contracting members, creating charters, organizing and running all meetings, capturing all meeting details and providing assessments from the SMC. In addition, Drug Safety Solutions can also provide physicians as needed to other SMCs.
Medical Writing Services
Using our network of experienced medical writers and our experienced physicians, Drug Safety Solutions prepares and reviews a variety of regulatory documents and IND and NA submissions. Additionally, we regularly support final study reports, periodic safety updates, annual reports, etc. for investigational and post-marketing trials. Drug Safety Solutions personnel write narratives for patients who discontinue use of a drug due to adverse events (AEs), experience laboratory abnormalities, or experience clinically significant events that require clear documentation for inclusion in the final study report.
Drug Safety Solutions prepares and/or presents medical and safety information—including the protocol, safety procedures, and the process and importance of collecting appropriate data—at investigator meetings. We firmly believe that an early investment in training the investigator, study coordinator, and support staff in protocol review and data collection results in a more concise, accurate and presentable end product.
We customize and present training materials specific to your study for both your team and the CROs. Our team training program includes a medical overview that clarifies the study protocol, and SAE reporting training to guide your team through the necessary steps to create accurate reports. This specialized training will increase your team’s understanding of the study data—allowing them to judge the information they receive more effectively and efficiently.
Audit and Advisory
Companies worldwide now have greater need for adverse event trends and signal detection, identification of potential vulnerabilities, internal audit, risk management, and corporate governance.
Our core audit practice and specialty advisory services can help you deal effectively with the myriad of issues facing compliance and statistic review of safety data. You can expect consistent, seamless service with your internal safety departments. In every case, we apply the same methodology of cooperation, knowledge sharing, technology, and real-time collaboration. Our commitment to the quality of our audits is demonstrated by our consistent methodology and the thorough quality controls we apply to every client engagement.
Our substantial investments in learning resources for our safety professionals allow us to deliver quality services to our clients. Following the appropriate professional standards, our audit teams provide these services:
- FDA Safety Compliance Attestation – We examine and attest to your company’s regulatory compliance reports.
- Internal Control Reporting – We evaluate and report on management’s assessment of internal control over drug safety reporting.
- Related Services – In today’s globally connected world, your success is directly linked to maintaining the confidence of your stakeholders.
We can help you by assessing your procedures and controls relating to privacy and confidentiality, performance measurements, systems reliability, information security, and outsourced process controls.
We design a customized audit plan that concentrates on the business areas significant to your drug safety statements and critical to your risk profile.The result is not only an efficient audit—it is also an effective one. Our early identification of trend, signal and trigger control vulnerabilities makes it possible for us to focus our audit effort on those areas of greatest risk.