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. CRES’ professionals oversee all aspects of your investigation, from site activation to get your research underway as swiftly as possible.
Starting Up Clinical Studies Efficiently & Swiftly
Launching a clinical study is a gargantuan task. Throughout clinical development, from patient recruitment through study completion, you must conduct a variety of complex and tightly regulated processes.
Increased pressure to minimize expenses and shorten timetables, combined with patients who are difficult to identify, poses a challenge. This is particularly true as trials grow globally, patient groups become more defined, and investigator locations become more remote. CRES, of course, is prepared to support you with our Clinical Study Start-Up services.
Site Initiation
We make sure that the clinical site is ready to recruit patients in your clinical trial during the Site Initiation.
In addition, we assure practicality from access to platforms and systems that the study team employs during the study, on-site availability of the investigational product, and completion of the relevant regulatory documentation, consent and approvals.
Informed Consent
For most countries, you must adopt the Informed consent form according to the local standards and file in the local language.
Our startup professionals oversee the evaluation process and guarantee you fulfil the timeframes specified by authorities. As a result, delays in site activation can be minimized, and you can promote steady enrollment in your study with an in-depth and early conversation.
Monitoring Phase
Cres focuses on implementing effective risk mitigation from the outset of the study. The cornerstone of our multifunctional approach includes communication links across operations and emphasis on subject safety, high-quality data, and risk evaluation.
We establish a review process to deliver consistent data with a degree of flexibility for adaption to various sites. Throughout your study, we provide statistical monitoring and targeted centralized data review taking the respective risk level for that stage into account.
Biostatistics & Analysis
Cres’ Biostatisticians are engaged from the get-go of your study. We ensure that both the sample size, hypotheses, and statistical models ensure the highest degree of confidence in your desired outcome.
It is also commonly acknowledged that a properly-designed database and statistical input into the trial’s risk assessment assist trials greatly, ensuring that all of the evaluation’s possible risks are recognized and managed from the start.
Medical Writing & Publications
Cres’ medical writers assist you in developing well-structured scientific documentation for clinical trials.
Our regulatory medical writing services include the preparation of regulatory paperwork for national authorities and local ethics committees, as well as the documentation required for your clinical study.
End-To-End Management
Our adaptable and dynamic operational strategy, together with an internal pool of highly motivated Clinical Research Associates, enables us to overcome even the most complicated obstacles and assist you in meeting milestones.
In addition, to start up, we offer an end-to-end solution for Trial Management.
Partients can’t wait. Accelerate your Clinical Study Startup.
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.
