Clinical Trial Management
Our diverse and dynamic operational style, coupled with a pool of highly motivated in-house Clinical Research Associates, enables us to solve even most complicated issues and help you accomplish milestones.
End-To-End Support To Deliver Success
We’re constantly modifying and inventing new, imaginative distribution methods to keep you one step ahead. In addition, we have a breadth of knowledge in many therapeutic areas and across all clinical development disciplines.
Managing clinical trials is just as much about the people engaged for us as the data. Therefore, we provide Clinical Research Associates that work with you and your team on-site. Their awareness of legal standards, compliance, and regulations, as well as their passion, energy, and commitment, make them an outstanding choice to ensure your Clinical Development realizes its maximum potential.
Complete outsourcing or co-creation? That’s your choice. We tailor our approach to your needs.
We can support you every step of the way. Wether you need us to perform a medical unmet need analysis or elicitate experts our you need us to support reference development, we’re ready when you are.
To amplify your strategy, we can be involved in the co-creation of complete Business Plans, dealing with sponsors, and helping you prepare bids for institution sponsorships.
Clinical Project Management
Our Clinical Project Managers are in charge of the design and coordination of clinical trials encompassing drugs, medical devices, and diagnostics.
By maintaining a continual attention on the trial’s progress, we can trust and confidenly answer to any clinical queries, accomplish timelines, and surpass expectations.
Trial Design
Our approach ensures accurate data transmission and minimizes changes to your clinical development strategy and associated delays.
While clinical development might be daunting, Cres’ expertise in patient outcomes enables you to enhance your clinical development efforts through a risk- and data-driven mindset. We begin our design process with access in mind.
Vendor Qualification
Regulators expect pharmaceutical companies to verify contracted vendors have adequate qualifications to complete their contracted work. These requirements can significantly impact your planning if not adequately managed. Cres’ professionals are at the ready to support you with a Quality check and investigate Accreditation.
Our clinical experts can also be involved early on to assists you in setting the right criteria for selection, bargaining, and contracting new vendors following our well-thought out workflow.
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.
Clinical Research Academy
We see training as a crucial step to assist you attain your growth objectives. We strive to be the greatest in clinical research research teducation and, for us, training is a vital aspect of increasing clinical development.
Clinical Research Academy specializes in creating and delivering theoretical and practical training for clinical trials of medicines and medical devices.
“Leave nothing to chance for your Clinical Trials. “
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.
