Our Services
Market Research
Patient Identification
Patient Identification
Your most important and 1st step to the market. Learn market dynamics and environment before you start
Patient Identification
Patient Identification
Patient Identification
Accelerate Patient Identification & Recruitment Process for your Clinical Trials, let experience and knowledge do the job.
Early Access Programs
Early Access Programs
Early Access Programs
Setting an Early Access Programs is a long-term process that has to be performed meticulously.
MARKET RESEARCH
Market Research Mastery
In the dynamic landscape of rare diseases and orphan drugs, conducting effective market research is paramount. At PharmaRares, we define our work by delving into the intricacies of these specialized fields to offer tailored market insights.
Challenges in this niche market include:
- Limited data and understanding of patient populations and demographics for rare diseases.
- Identifying optimal target markets and key stakeholders for orphan drugs.
- Navigating complex regulatory landscapes specific to rare diseases and orphan drugs.
- Recognizing emerging trends and competitive intelligence within the industry.
Our solution lies in leveraging the extensive expertise of our team. PharmaRares addresses these challenges by:
- Conducting thorough analyses to define patient populations, ensuring targeted and impactful market research.
- Identifying and engaging with key stakeholders, including patients, healthcare professionals, and regulatory bodies.
- Navigating intricate regulatory pathways, ensuring compliance and strategic positioning.
- Providing up-to-date market intelligence, allowing clients to stay ahead of emerging trends and competition.
PharmaRares is your dedicated partner in conquering the challenges of market research in rare diseases and orphan drugs, ensuring your strategies are informed, precise, and primed for success.
Let's meet and tailor the service for you Contact Us
PATIENT IDENTIFICATION
Unlocking Success In Clinical Trials
As the name implies, rare diseases are indeed uncommon and can be challenging to diagnose. This challenge often results in the difficulty of identifying a sufficient number of eligible patients for recruitment to clinical trials.
The hurdles faced include:
- Identifying the specialty of the treating physician and locating physicians nationwide who specialize in the specific disease.
- Low awareness of the disease among healthcare professionals and authorities.
- The absence of a diagnostic method for the disease outlined in the clinical trial protocol.
- Selecting the Principal Investigator (PI) and the appropriate center to conduct the clinical trial.
- Choosing an experienced Contract Research Organization (CRO) in the specific field.
- Delays in obtaining authorization for the clinical trial due to governmental stakeholders.
Our solution lies in recognizing these challenges and leveraging the expertise of our team. PharmaRares is committed to guiding you through every step, addressing potential setbacks that may arise from unfamiliarity with the country and its processes. Our team's extensive experience in rare diseases, regulatory affairs, identification of suitable medical centers for clinical trials, collaboration with healthcare professionals, partnering with established CROs, knowledge of diagnostic centers and pathways, and close relationships with involved parties ensure a swift and trouble-free setup for your clinical trial.
Let's meet and tailor the service for you Contact Us
EARLY ACCESS PROGRAMS
Named Patient Programs
In the realm of rare diseases, PharmaRares is at the forefront of crafting innovative Named Patient Programs in accordance with the dynamic and ever-changing regulations stipulated by TİTCK (Turkish Drug Agency). We are dedicated to defining our work by seamlessly navigating the intricacies of "Yurtdışı İlaç Temini," (Imported Drugs Regulations) offering robust and compliant solutions for companies setting up Named Patient Programs in Turkey.
Challenges within this intricate landscape include:
- Adhering to stringent regulatory requirements set by TİTCK for importing and supplying unlicensed medicines.
- Complex documentation and application processes for Named Patient Sales, requiring a deep understanding of Turkish regulations.
- Ensuring timely and lawful access to medications for patients with rare diseases.
- Identifying key stakeholders, including treating physicians, and finding eligible patients.
- Navigating the complex landscape of healthcare professionals and regulatory bodies/authorities.
- Addressing the complex reimbursement procedures applied by SGK (Social Security Institute).
- Managing the supply chain intricacies and navigating complex procurement procedures run by TEB (Turkish Pharmacists' Association) or SGK İbn-i Sina Drug Procurement Center.
PharmaRares excels in providing comprehensive solutions by:
- Navigating and ensuring compliance with TİTCK regulations for the importation and supply of unlicensed medicines.
- Streamlining documentation processes, leveraging our deep understanding of Turkish regulations.
- Facilitating expedited access to crucial medications for patients with rare diseases.
- Identifying key stakeholders and eligible patients to ensure targeted and impactful Named Patient Programs.
- Establishing a reliable network within the complex landscape of healthcare professionals and regulatory bodies/authorities.
- Addressing and simplifying the complex reimbursement procedures applied by SGK.
- Managing the supply chain intricacies and navigating complex procurement procedures, ensuring adherence to legal and regulatory standards set by TEB or SGK İbn-i Sina Drug Procurement Center.
PharmaRares remains your dedicated partner, offering unparalleled expertise in Named Patient Sales to overcome the multifaceted challenges of regulatory compliance, stakeholder engagement, and streamlined access pathways for essential medications in Turkey.
Let's meet and tailor the service for you Contact Us
Compassionate Use
PharmaRares is your beacon for crafting Compassionate Use Programs in alignment with the guidelines set forth by TİTCK (Turkish Drug Agency) through the Compassionate Use Program Guideline "İnsani Amaçlı İlaca Erken Erişim Programı Kılavuzu."
Challenges include:
- Navigating the stringent regulatory landscape for early access to unlicensed medicines.
- Meeting complex documentation and application requirements outlined in the guideline.
- Ensuring timely and lawful access to vital medications for patients with rare diseases.
PharmaRares provides tailored solutions by:
- Ensuring adherence to TİTCK guidelines for the establishment of Compassionate Use programs.
- Streamlining documentation processes, leveraging our deep understanding of Turkish regulations.
- Facilitating expedited access to crucial medications for patients with rare diseases.
PharmaRares stands as your dedicated partner, offering expertise in Compassionate Use to navigate regulatory complexities and provide a swift and lawful access route for life-changing medications in Turkey.
Let's meet and tailor the service for you Contact Us
STRATEGIC PARTNERSHIP
Detail your services
At PharmaRares, we redefine B2B collaborations through strategic partnerships that transcend conventional boundaries. Our commitment is to empower your success by providing tailored solutions in the complex landscape of rare diseases and specialized medical programs.
Challenges abound in the healthcare and pharmaceutical sectors, from stringent regulations to intricate market dynamics. Here's how our strategic partnerships make a difference:
- Tailored Solutions for Regulatory Excellence: PharmaRares collaborates closely with our clients to navigate intricate regulatory landscapes. Together, we design tailored solutions ensuring compliance, expediting approvals, and mitigating regulatory risks.
- Market Insight and Expansion: Leveraging our expertise, we provide valuable market insights. Our strategic partnerships are designed to identify opportunities, optimize market positioning, and drive successful market entry and expansion strategies.
- Stakeholder Engagement and Relationship Building: Understanding the importance of key relationships, we foster stakeholder engagement. PharmaRares works hand in hand with our clients to build and nurture relationships with healthcare professionals, regulatory bodies, and other vital stakeholders.
In every aspect, PharmaRares stands as your dedicated partner, fostering a collaborative environment for mutual growth and success. Through strategic partnerships, we embark on a journey to overcome challenges, capitalize on opportunities, and create a lasting impact in the dynamic landscape of rare diseases and specialized medical programs.
Let's meet and tailor the service for you Contact Us