Clinical Study Start-Up
Study start-up can be unpredictable, and it is vital to keep costs and quality under control while minimizing the time necessary to activate your site. Isheo’s professionals oversee all aspect of your investigation, from site activation to getting your research underway as swiftly as possible.
Advancing your goals
Initiating a clinical study is a monumental task. You must execute a range of complicated and closely controlled operations throughout clinical development, from patient recruiting to study completion.
Increased pressure to cut costs and shorten schedules, along with difficult-to-locate patients, creates a problematic situation. This is especially true when studies expand internationally, patient groups narrow, and investigator sites become more distant. Needless to say, Isheo is ready to assist you with our Clinical Study Start-Up services.
Our CRO services are executed through our affiliated company CRES. We also offer:
We make sure that the clinical site is ready to enrol subjects in your clinical trial during the Site Initiation.
In addition, we ensure practicalities from access to platforms and systems that the study team uses during the study, on-site availability of the investigational product, and completion of all necessary regulatory documentation, consent and approvals.
For most countries, you must adopt the Informed consent form according to country local requirements and submitted in the local language.
Our startup specialists manage the review process and ensure you meet the timelines set by authorities. A thorough and early discussion early on helps mitigate delays in site activation and instead promote steady enrolment in your study.
To ensure a sound budget and effectively operationalize your study, it is paramount that you write an effective study protocol and SOPs.
We provide support in this area for investigator-initiated and industry-sponsored studies and engage top KOLs and scientist to help you identify what questions you need to answer.
Trial Master File
Adequately managing the TMF is critical in ensuring that all stakeholders, including the Investigator, Sponsor, and Institution, deliver high-quality data.
Isheo’s experts can help you build your Trial Master File and collect all information to demonstrate you completed your study following relevant regulatory standards like Good Clinical Practice.
Local Regulatory Approvals
Our experts help to prepare the required documentation and approvals to initiate your trials on schedule.
On your behalf, we can also liaise with the clinical team to help compile initial and amended regulatory document packages, track the status of your regulatory readiness and inform the Clinical Study Coordinator of challenges that might delay your trial.
Site Feasibility & Selection
Our systematic approach to assessing the feasibility of your study is focused on establishing a consistent method that eliminates bias and enables objective site assessment.
By engaging your trial’s Investigators in meetings early on, we positively impact clinical study quality, trial timelines and promote investigator participation.
“No detours, no delays but efficient start-up of your study. “
Start a conversation
Please feel free to contact us. We’re always glad to offer you our support, discuss how to generate new evidences and disseminate results of modern-day advances in medical science. We will be glad to listen to you, and we will turn back to you with a tailored strategy, a detailed plan of activities, and a mindset to help you advance your goals.