Site identification for a clinical study: Involves evaluating and selecting locations based on patient demographics, facility capabilities, and regulatory compliance to optimize trial feasibility. It prioritizes sites with qualified investigators, adequate resources, and strong enrollment potential, leveraging feasibility assessments, database reviews, or existing site networks.

Confidentiality Agreement Execution (CDA): Traditionally, the task of pinpointing optimal sites is both labor intensive and time consuming, involving exhaustive data analysis, patient accessibility assessment, and site suitability evaluations. Timely execution impacts overall study timelines and milestones, making effective CDA management indispensable. Execution of Confidential Disclosure Agreements (CDA) after selecting investigative sites, sponsors must swiftly execute CDAs. These documents, crucial for safeguarding sensitive trial information, often represent logistical headaches and frequent bottlenecks. Monitor CDA statuses transparently in real time no crystal ball or guesswork required. COSMOS offers a smarter approach to CDA execution, enabling sponsors and CROs to effortlessly create and disseminate CDAs to multiple sites simultaneously because nobody enjoys individually tracking hundreds of PDFs. Receive timely internal and external alerts when CDAs lag expected timelines. Sites, in turn, can seamlessly execute and return these critical agreements, streamlining what was previously a cumbersome, time draining chore. Through the intuitive COSMOS eCDA feature, sponsors can electronically generate and share CDAs directly via the portal. With COSMOS, gone are the anxious days of tracking down paperwork.

Conducting a thorough feasibility analysis is paramount, encompassing historical site performance data, an awareness of the competitive clinical landscape, advanced predictive modeling, country specific rankings, and realistic recruitment forecasts.

Site Feasibility Questionnaire (SFQ): Crafting an effective clinical trial begins with meticulous protocol design, thoughtful region selection, and grounded, realistic projections essentially laying down a precise blueprint to identify the ideal patient profile. Instead, sponsors enjoy clear visibility into every document’s lifecycle, transforming CDA management from tedious chaos into organized tranquility. With just a few clicks no elaborate incantations required you can seamlessly connect with clinical researchers, execute comprehensive site feasibility evaluations, review potential research sites or investigators, and select precisely the ones that align best with your study’s unique requirements. Indeed, site feasibility studies can sometimes feel like reading tea leaves, albeit with considerably more sophisticated tools. Enter COSMOS a revolutionary platform offering a suite of feasibility intelligence tools designed to bridge clinical researchers and potential sites globally effortlessly.

Pre Site Visit  (PSV): The Clinical Research Associate CRA engages with the principal investigator and their team, meticulously reviewing the study protocol to confirm genuine interest and suitability. The CRA further verifies that the facility’s infrastructure, equipment, and staffing capabilities align precisely with protocol requirements. Completing the Pre Site Visit (PSV). The PSV, affectionately known in the clinical trial world by various acronyms Pre Study Site Visit (PSSV), Site Qualification Visit (SQV), or simply PSV is an essential checkpoint designed to ensure research sites are perfectly suited for the upcoming trial. The platform streamlines the PSV process, supporting informed decision making and ensuring alignment, efficiency, and confidence before officially launching into full trial operations. COSMOS facilitates this critical evaluation seamlessly, empowering sponsors to thoroughly vet each research site and investigator. It’s like a careful dating process, ensuring mutual compatibility before fully committing to the long-term relationship inherent in clinical research.

Budget Creation and Negotiation: Our platform empowers sponsors, CROs, and research sites to build robust budgets effortlessly and optimize the entire Study Start Up process. COSMOS elegantly transforms this delicate art into a smooth, AI driven science. Digital Budget Creation and Negotiation navigating clinical trial budgets is traditionally an exercise somewhere between high stakes diplomacy and spreadsheet induced frustration. Leveraging cutting edge AI, COSMOS draws upon rigorously negotiated investigator grant data from past clinical trials, enhancing budget accuracy and reducing unnecessary friction. COSMOS expedites clinical trial startups by streamlining budget workflows and CTA negotiations within a transparent ecosystem. With advanced capabilities including 21 CFR Part 11 compliant eSignature functionality COSMOS significantly reduces the cumbersome back and forth typically associated with clinical trial agreement. COSMOS brings a refreshing digital solution to these archaic practices, significantly enhancing efficiency, accuracy, and compliance.

AI driven budget creation specific to therapeutic areas real time online budget sharing with research sites transparent online negotiation tools comprehensive audit trails tracking all negotiations Clinical Trial Agreements ( CTA). The CTA, essential and legally binding documents outlining each party responsibilities, traditionally involve lengthy email chains, tedious printing, scanning, and the inevitable risk of human error. With COSMOS CTM Contract Manager, sponsors can seamlessly share and execute CTAs through an FDA 21 CFR Part 11 compliant eSignature system. Sites can directly modify, finalize, and securely sign agreements within the platform no paper cuts or lost emails are involved.

Study Essential Documents: Essential documents are vital evidence of compliance with Good Clinical Practice (GCP), and regulatory standards, often scrutinized closely by regulatory agencies. By adopting COSMOS CTA manager, users can expect elimination of manual errors significant reduction in processing times removal of scanning related hassles preserving document integrity. Both sponsors and sites benefit from enhanced document visibility, assured compliance, and significantly reduced Study Start Up timelines. Sponsors can effortlessly distribute essential documents such as protocols, informed consent forms, FDA 1572, Financial Disclosure forms, and investigator agreements directly to sites via integrated portal. Managing these documents traditionally involves countless hours of scanning, emailing, downloading, and re uploading tasks more befitting administrative acrobatics than clinical excellence. COSMOS revolutionizes essential document management with its intuitive digital document handler. This innovative approach significantly boosts accountability, enhances traceability, and dramatically increases efficiency. The fully integrated COSMOS platform eliminates the tedious cycle of downloading and re uploading by directly transferring essential documents into the study regulatory binder rBinder. Sites can securely access, electronically update, and execute documents using COSMOS 21 CFR Part 11 compliant eSignature. With COSMOS, sponsors and CROs bid farewell to the relentless waiting games and cumbersome email exchanges, freeing their teams to focus more effectively on delivering successful, compliant clinical trials faster than ever before.

Site Initiation Visit (SIV): In a clinical trial is a critical meeting conducted by the study sponsor or Contract Research Organization (CRO) before a research site officially begins participant enrollment. During the SIV, the sponsor’s Clinical Research Associate (CRA) meets with the investigator and site staff to:

• Thoroughly review the study protocol, ensuring the site clearly understands all requirements.
• Confirm that all regulatory and ethical approvals are in place.
• Verify that the site has the necessary resources, equipment, and adequately trained staff.
• Conduct training sessions for the site staff on study procedures, data collection, and safety reporting.

The goal of the Site Initiation Visit is to ensure that the site is fully prepared, compliant, and ready to efficiently and safely conduct the clinical trial according to regulatory guidelines and protocol requirements.