Cromos Pharma

The market for medicines and medical devices is undergoing significant growth. Registration is the first step in pharmaceutical drug and medical device marketing and a key area of expertise within Cromos Pharma.

Сromos Pharma team has the necessary experience and knowledge in this area and provides a wide range of services related to the registration of medicinal products and medical devices in Belarus, Georgia, Russia, and Ukraine, including the following:

• Preliminary and gap analysis of submitted documentation
• Preparation of registration dossier (CTD format for medical product)
• Changes to registration certificate
• Development of normative documentation
• Notarization of regulatory documents in accordance with national legislation across several jurisdictions
• Development of technical and operational documentation (for registration of medical devices)
• Translation of all necessary medical documents
• Submission of registration dossier to the regulatory authorities

Our Regulatory Affairs Department provides comprehensive services related to the registration of medicinal products and medical devices in an efficient, timely and cost-effective manner, coordinated in accordance with all applicable local regulatory requirements of the country of interest as required by the Client.

Cromos Pharma offers a full range of clinical data management and biostatistics services via long-established, trusted and validated partners from European Union and USA.

Biostatistics

• Study design consultation
• Study protocol development
• Informed Consent Form preparation
• Sample size calculation
• Randomization code list generation
• Statistical analysis plan development
• Statistical analysis programs development and validation
• Statistical analysis conduct
• Generation of customized tables, graphs, and data listings
• Statistical interpretation of study results
• Mining of study results descriptions in medical narratives
• Study report writing
• Assistance in preparation of study results for presentations
• Assistance in manuscript preparation

Cromos Pharma offers a full range of clinical data management and biostatistics services via long-established, trusted and validated partners from European Union and USA.

Clinical data management

• Case Report Form (CRF) development/validation
• Customized database design/validation
• Data entry screen design/validation
• Double data entry
• Programming under SAS
• Data validation (manual check, computerized edit checks, medical expertise)
• Data listings
• Presenting data in the format & structure convenient for the client
• Data transfers
• Data coding

Cromos Pharma has built a very strong team of medical writers with considerable experience in medical and regulatory writing services. Our aim is to create concise, well-structured documents that will satisfy the requirements of multiple regulatory authorities in various countries. Adhering to local regulatory guidelines, international standards and scientific integrity are critical components in the development and delivery of all Cromos Pharma's study documents.

Cromos Pharma’s medical writing team comprises qualified MDs many of which also hold a PhD degree. Within the last five (5) years our team has developed comprehensive documents for Phase I-IV studies within multiple therapeutic areas, including oncology, cardiovascular diseases, respiratory diseases, urology, ophthalmology, dermatology, infectious diseases and many more.

We offer the following medical writing services:

• Study concepts and outlines
• Clinical study protocols and amendments
• Investigator brochures (IB)
• Patient informed consent forms (ICF)
• Clinical study reports (CSR)
• Executive summaries for efficacy or safety
• Reviews of clinical and nonclinical data
• Patient narratives
• Abstracts, posters and journal articles

Every pharma or biotech company requires a straightforward, fast and cost-effective development path for its pipeline products. A critical component of this pathway is detailed comprehensive planning of the clinical development program. We understand this process and for all our studies we actually “walk the path” of what it takes to move your product through the hurdles, identifying in advance all risks and potential gaps in the process. The start of every project and recruiting the first patient is a major milestone. We believe that by thorough and adequate pre-planning and carefully mapping the A to Z of securing the first patient we save our clients’ time and budget.

The majority of our personnel have worked in large and small pharmaceutical companies and in international CROs, and have a thorough understanding of the costs, time and challenges in progressing a product from research through to marketing authorization. Our expertise spans all stages of the clinical drug development: from selection of study type and patient population to selection of countries with the most effective ratio of costs, quality and timelines of a clinical study, to project management, analysis and registration of a product. Moreover, we have built considerable expertise in identifying, recruiting and retaining eligible patients, a key challenge in all studies.

Services related to advice on clinical development programs include:

• Consultation on study types required for drug registration
• Development of study design and outline with core elements
• Negotiation with regulatory authorities on study design
• Discussion of study concept with world and national opinion leaders
• Capability of study execution in various countries
• Budgeting of study-related activities

Protecting the health and safety of trial participants is extremely important to us at Cromos Pharma. We take a special approach to site selection and in choosing Investigators. While most companies face challenges in subject recruitment and retention, Cromos is one step ahead and consistently on track when it comes to achieving the “Last Patient In” target. Our key focus is on maintaining our extensive professional network which has consistently delivered patients supportive of the clinical trial research process.

By analyzing study population, sites’ motivation to enroll, type of disease, subjects’ barriers to participate in studies (e.g. travel distances, a number of clinic visits), we have developed a significant resource that facilitates identification, recruitment and retention of the precise type of patients required across a broad range of studies.

PATIENT RECRUITMENT AND RETENTION SERVICES

• Promotional and educational materials: we work with Investigator teams to implement different tools aimed at increasing subjects’ interest in enrolling in new treatments and participating in clinical trials (brochures, posters, reference tools).
• DTC outreach: we assist Investigators in increasing the awareness among potential participants of clinical trials by organizing of seminars for participants and their families in order to familiarize them with the clinical trial process and how such research contributes to the development of new treatments. We additionally assist Investigators in the business of digital marketing, website, social media, mobile applications, all critical tools in ensuring that both clinicians and patients become aware of relevant studies.
• Investigator’s materials: site recognition program, distribution of newsletters, designing mini-protocols for clinical staff, inclusion/exclusion criteria cards.
• Booster visits: face-to-face meetings with all Investigator site team members.
• Referral sites: database with contact information physicians (out-patient department, private hospitals, regional hospitals) with whom agreements on recruitment of patients for participation in clinical trials are signed.
• Commitment to patients: creating reimbursement procedures (taxi, accommodation, meals vouchers).
• Patient’s materials: patient newsletters, welcome packet, visit calendar and reference cards.

Cromos Pharma manages both single- and multi-center phase I-IV trials and bioequivalence studies in a wide range of therapeutic areas.

Our project management teams are proactive, with efficient communication across the spectrum. Responsibilities, processes and reporting lines are clearly defined at a very early stage of each project. With every study, we appoint an experienced Project Manager (PM) with in-depth knowledgein the study field and this PM acts as a primary liaison for the Sponsor ensuring your study receives absolute priority, that all timelines are managed to schedule, quality is maintained, appropriate training is delivered and the budget is adhered to.

We employ only experienced physicians to monitor our clinical trials. They are citizens of respective countries, fluent in English, have intricate knowledge of the local medical community and intricate knowledge of its medical practices and standards.

Our CRAs have undergone extensive training to ensure comprehensive adherence to ICH GCP standards and have at least 3 years industry-related experience.

While working with us you can be assured that the lead CRA assigned to your study will manage all site-related activities from initial RFP through to close out. It is extremely rare in Cromos Pharma for a CRA to be replaced once the study starts, an industry metric that we are very proud of. A keystone policy within Cromos Pharma is to keep the same CRA for the lifetime of the study which ultimately benefits the Sponsor and the study.

Cromos has dedicated staff available 24/7 to reply to study inquiries and to support our Sponsors and Investigators.

It is well known how important feasibility reports are for timely enrollment and successful conduct of a study. We use our local knowledge and expertise in site selection to evaluate all aspects of your proposed study, including regulatory issues, epidemiology, limitations of enrollment, challenges with logistics, support with the importation of different clinical trial materials and timelines for approval by regulatory authorities.

To obtain reliable perspectives on the study, our feasibility approach builds on personal relationships and communication with Principle Investigators and Key Opinion Leaders (KOLs), rather than on generic distribution of questionnaires. We have excellent personal contacts with a significant number of opinion leaders and scientific experts who are willing to act as Principal Investigators and/or as members of Scientific Advisory Boards for our clinical trials. Our well-established relationships with local medical communities give us direct access to key scientists at principal clinical research centers across our jurisdictions.

Cromos personnel have experience in the organization of protocol draft review by local key opinion leaders, which allows our clients to obtain independent feedback from scientific and practical points of view at an early stage of protocol development. Additionally, we use "the closed cycle" for the start-up process in our company: on a regular basis we involve Clinical Operation teams, Regulatory Managers and medical writers for comprehensive capability/feasibility assessment. Establishing early and in-depth contributions from all our departments in the process of protocol development adds significant value at later stages in the study.

We strongly believe that careful selection and evaluation of Investigators is critical to the successful enrollment and quality of our studies. Consequently, we have created a sophisticated database of potential Investigators in addition to implementing a proprietary system to evaluate their performance at the end of each study.

What differentiates Cromosfrom our competitors is a unique method of site selection that is based on:

• Experience with more than 800 sites in most therapeutic areas since 2004
• Electronic Internal Investigators/Sites database (detailed contact information for 2,109 Investigators and 1,711 Study Sites)
• Long-established operating activities in Central and Eastern Europe (Bulgaria, Croatia, Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Romania, Slovakia, Slovenia) and post-Soviet region (Russia, Ukraine, Georgia, Belarus, Armenia, Moldova, Kazakhstan, Uzbekistan)
• Collaboration with validated partners in North and South America regions
• Proprietary and customizable Electronic Feasibility Questionnaire
• Investment into long-term relationship with investigators
• Active consultations with country-specific key opinion leaders
• Working with leading medical centers and tertiary hospitals guarantees high quality of clinical research and rapid recruitment
• Mapping of competitive trials helps avoid slow recruitment

Our regulatory affairs professionals have in-depth knowledge of national legislation, in addition to extensiveclinical trials expertise in working with regulatory agencies (RA) and ethics committees (EC) in multiple jurisdictions within Eastern Europe (e.g. Czech Republic, Hungary, Latvia, Lithuania, Estonia, Poland, etc.) and ex-USSR (e.g. Belarus, Georgia, Russia, Ukraine, Moldova, Armenia, Kazakhstan, Uzbekistan). We are committed to diligent preparation of all documents for RA and EC submission and we make sure that regulatory approval procedures managed by our team run smoothly and without delays.

We provide the following services:

• Compilation of initial submissions, amendments, notifications, and closeout submissions to RA and ECs
• Customization/review of informed consent documentation
• Negotiation with insurance companies on compulsory trial subjects' insurance
• Comprehensive regulatory support throughout the study
• Obtaining of import/export licenses for the study drug and biosamples
• Regional regulatory consultation