Clinical Trial Safety Operations

A protocol not only details the study background along with reason and objectives it also defines the study design, methods, inclusion criteria and statistical considerations making it the most essential document used in clinical trials setting that describes the study conduct process. Hence, we emphasize on establishing uniform study conduct standards that enable our Sponsors to arrive at reasonable conclusions despite collating information from various study centers. Protocol review includes detailed validation of processes defined to confirm effectively study completion with available capabilities and resources. Our team of experts engage in scrupulous review of protocols to ensure key details regarding rational for study, participants, study design and data gathering while complying with protocol development guidelines.

Configuration of study is a pivotal activity in the new age electronic collection and management of clinical trial data both in clinical and safety databases. Study configurations aids in data compartment related to specific trail along with on demand retrieval that is accurate and reproducible. We are experts in creating studies by providing characteristics information relevant to the study using sensibly designed templates that captures data and transformations that are checked by validation. Our team of experts also help our Sponsors to create custom listings using filters and static references enabling our Sponsors to gain control and flexibility in designing and setting up clinical trials.

The methodical data capture during clinical trial and planned follow-ups always ensure that the safety data generated during trials are comprehensive. However, consistently maintaining a robust process for reporting has always been a challenge. We are committed to safety in clinical trials support our Sponsor to maintain high standards of quality and compliance. Our expert team is proficient in case processing and management of cases from different studies like interventional, non-interventional and solicited. We ensure timely submissions to Health Authorities with our expertise in interpreting case reports for their seriousness, causality and expectedness. Our attention to data archival always helps our Sponsors during application for authorization, representations in master files and regulatory inspections.

Unblinding is a unique decisive means often used to mitigate foreseen risks or unanticipated issues in a blinded trial where either investigator or subject or both are not aware of the treatment modality. Unblinding of cases involves removing the blind leading to identification of treatment and interventions received by the subject. We are experts in deploying stringent procedures and accurate documentation for unblinding during clinical trial to ensure compliance to regulatory requirements. Our expert team are proficient in interim analyses that help our Sponsors to evaluate efficacy disparity and safety profile among treatments. We also support our Sponsors to identify new scientific evidence and benefit-risk reassessment to help them end their clinical trials early, if required.

Some Health Authorities mandate submission of medical assessment of safety reports along with Analysis of Similar Events (AOSE) that provided meaningful insights and assessment of relevant events in conjunction with similar preceding reports and other relevant data. Our expert team develop analytical insights in safety during compilation of AOSE which is primarily required by United States Food and Drug Administration (USFDA) for Suspected Unexpected Serious Adverse Reactions (SUSAR) originating from interventional clinical trials sponsored by company and SUSAR originating from investigatory sponsored trials outside United States. The compilation of AOSE is also required by Swiss Medic for Suspected Unexpected Serious Adverse Reactions (SUSAR) originating from interventional clinical trials sponsored by company within Switzerland and serious unlabeled events in Individual case safety reports (ICSR) originating post marketing safety surveillance within Switzerland.

Development Safety Update Report (DSUR) is a harmonized safety document used to assess relevant safety data and summarize the investigational products safety throughout clinical trial development phase. The current ICH E2F DSUR format is accepted by most Health Authorities in regulated market and submitted in the first authorization year of the clinical trial followed by annual reports until final study conclusion. This format enables ongoing risk evaluation and is mostly inspired by the Periodic Safety Update Report (PSUR) format used to detail post marketing drug safety summaries. We are well equipped to offer complete development of safety documents for our customer that includes all DSUR components as well as customized services for clinical review, sign-off, literature summary and analysis, and suggest company comments.

Parallel recording of safety data in clinical and safety repositories like databases during the clinical trial process is an established process that requires reconciliation to confirm consistent and complete safety monitoring during clinical trial. Our expert team emphasize on careful early planning of this critical step that benefits our Sponsors by avoiding quality issues and unnecessary delays during the new drug approval phase. Our methodical approach and sound knowledge in managing safety data for both clinical and safety domains empower our multiple-disciplinary experts to cautiously decided what to be reconciled with whom on a timely manner. We can also customize our services to support ongoing reconciliation and modifications post initial severe adverse events reconciliation.

Investigator’s Brochure (IB) is a descriptive document for a pharmaceutical molecule undergoing investigation that provide Investigators and Sponsors with an insight of the summary of manufacturing process, methods of administration, dosing regimens, Serious Adverse Events, Adverse Events, procedures pertaining to safety monitoring, and all the clinical and nonclinical study results. An IB facilitates an Investigator to better comprehend the aim of the clinical trial. Our team of expert Medical Writers seamlessly ensure to deliver well written IB in a simple, balanced and concise format while keeping them non promotional and including an objective to enable an investigator to conclude to an unbiased risk imposed on subjects involved and potential benefit assessment. We are experts in performing the annual review of the IB and handling ad-hoc updates in compliance to Health Authority requirements throughout the clinical development phase.

Critical safety information originating during clinical development phase should be immediately notified to all investigator. These primarily included findings signifying high risk or serious adverse reactions experienced by subjects especially if these are suspected and unexpected. Our experts devise customized communication protocols and maintain extensive contacts of participating investigators enabling our Sponsor to avoid logistical and operational challenges in notifying newly identified safety information. We can tailor our service to collaborate with Sponsor’s drug safety and clinical safety groups along with investigators or entirely manage Investigator Notification on behalf of our Sponsors proficiently.