STRATEGIC CONSULTING

Customized Solutions From Chiron Medical Professionals

With the assistance of our well-trained teams, our functional experts offer specialized services beyond the scope of basic CRO offerings and can implement impactful, well-suited solutions.
Chiron Medical is a full-service CRO that can offer complete solutions for the implementation of complex development programs in addition to strategic consultation to assist with program planning. To be more precise, Chiron Medical is one of the very few organizations that can help a sponsor navigate the particular difficulties associated with doing research in rare diseases because of our vast experience with trials and NDA and CTD filings in these fields. As a program develops, our level of creative consulting can be adjusted to fit each phase.

Chiron Medical Professionals: Your Partner in Crafting Customized Trial Success.

Chiron Medical: Your Trusted Partner in Clinical Trial Consulting.

Clinical Trial Consulting

Our experts are equipped with the knowledge and skills to not only carry out clinical studies but also counsel customers along the clinical development pathway, having supported a variety of clinical trials ranging in complexity. From the clinical studies part to the post-marketing stages of development, we are able to assist clients in making decisions according to GCP, trial protocols, local regulations, guidelines and legal announcements.
Clinical trials are getting more competitive, complicated, and time and cost constrained. Our clients are examining the best course of action in this difficult environment to meet their goals and proceed to the next stage of the development process while adhering to budgets and schedules. Our team assists in offering guidance on how to use best practices, understand local regulations, regulatory agency (TMMDA) guidelines, local Ethics Committees' requirements, recommendations, and organize clinical studies in a way that minimizes effort, time, and expense while obtaining the necessary answers to advance to the next stage of development. We accomplish this by utilizing a cooperative work style and the guidance of key opinion leaders (KOLs) and long-lasting and strong relationships with ethical committees and TMMDA.

The following actions are among them, including but not limited to
  • Suggestions for trial design that prioritize achieving desired outcomes with the least amount of time, cost, and effort
  • Applying state-of-the-art techniques, particularly for specific subject groups that meet restrictive inclusion and exclusion criteria, such as adaptive designs and predictive models
  • Operational plan for clinical trials on the ground that identifies possible obstacles and has several tiers of risk mitigation strategies in place
  • Suggestions for choosing a clinical trial site that will increase the chances of meeting or exceeding subject recruiting goals
  • Strategy for recruiting subjects
  • Development Strategy for Medical Devices
  • Establishing biomarker endpoints for clinical trials that are predictive, prognostic, and diagnostic
  • Suggestions for choosing imaging and lab partners in Turkiye
  • Complete examination of project schedules and key documents
  • Determination of root cause issues and significant risks, then implementing CAPA plan stricly for each issue.
  • Suggested strategy for immediate corrective actions to boost project performance
  • Experienced personnel to carry out action plans as required.

     For any kind of clinical trial projects, our team has successfully benefited our sponsors or global CROs by:

  • Accelerating deadlines
  • Budget realignment within the scope
  • Adjusting scope to better suit project requirements
  • Adding new personnel to the study team
  • Addition of an experienced principal investigator who will contribute to patient recruitment

Our methodology is predicated on an interactive partnership between the internal project team of the sponsor and Chiron Medical, as well as ongoing          assessment of project performance and objective outcomes  . 

Regulatory Consulting: Assistance during the regulatory cycle

An in-depth understanding of the local regulatory requirements is critical to successfully negotiate through its complexities and changes. Chiron Medical ensures compliance with the standards and guidelines set out by regulatory agencies in Turkiye by offering advice and help to pharmaceutical and biotech companies in the implementation of regulatory plans.
At every stage of drug development, Chiron Medical offers regulatory consulting services to sponsors in order to assist them reduce risks and streamline their decision-making procedures. These services include study design, regulatory compliance, protocol preparation, and patient recruitment.
Chiron Medical offers regional support, with a particular emphasis on Turkiye given our Turkish footprint, and is present in all key clinical trial destinations. To guarantee the success of sponsors' clinical trial development plans, we have local experts with years of experience and connections to regulatory bodies that can help them navigate the peculiarities of local regulations. Our methods are customized for every clinical trial, and our regulatory team assist clients in effectively navigating the regulatory procedure in the most cost effective and timely way possible to initiate the projects in Turkiye.

Chiron Medical: Your Gateway to Regulatory Success in Clinical Trials.