CRO Services

Clinical trial planning and design is one of the most important steps for your clinical trial’s success. This is why we make sure that every stage of the clinical development of your product is fully covered. What we do:

• Clinical Development Plans
  We create complete clinical development plans to ensure the success of your trial.
• Scientific Advice Meetings Preparation
  We organize scientific advice meetings to guide you in presenting your study design, help you address regulatory queries and optimize your regulatory approval.
• Regulatory Guidance Review & Advice
  We perform in-depth evaluations of regulatory guidance documents, keeping up with changing rules and regulations. We provide insightful advice, ensuring that your trial design aligns with current regulatory expectations.
• Statistics-related Regulatory Issues
  Our rich expertise in navigating statistics-related regulatory issues will help you in the design of robust methodologies and addressing statistical concerns raised by regulators.
• Market Authorization Support
  Comac Medical’s team will collaborate closely with you to compile and submit regulatory submissions, ensuring compliance with regional requirements.

Clinical trial planning and design is one of the most important steps for your clinical trial’s success. trial project management as the cornerstone of success. Our commitment lies in ensuring seamless coordination and efficient resource allocation to keep your study on track.

Our project management teams are proactive and skilled at foreseeing and overcoming challenges with tailored solutions. We uphold the highest standards of quality and efficiency.

Throughout the entire project duration, we offer meticulous oversight, precise coordination, regular status updates, comprehensive patient tracking information, and key performance metrics. Trust us to navigate your clinical trials with precision and dedication.

Our project management services include:

• Develop and manage project management plans;
• Meet enrollment targets;
• Control of clinical study execution;
• Risk management: fast identification and communication;
• Maintain excellent team communication;
• Ensure timely delivery of project milestones.

Global feasibility looks at whether a clinical trial can work well in different countries and regions and must be applied at the very beginning of the study planning. Our team will work with you to choose the right strategy for your study.

Detailed and precise feasibility data helps the sponsors and researchers make informed decisions about the design, logistics, and implementation of the trial – factors that contribute to the success of the clinical development program.

What we look for:

• Regulatory Environment – reviewing each country’s regulatory requirements and approval timelines for clinical trials;
• Patient Population – exploring the availability and suitability of the target patient population in different regions;
• Site Infrastructure and Capabilities – we make sure that the chosen sites are capable to conduct our client’s trial in the best way, that they can enroll the right patients, have the facilities needed, that they have qualified investigators and experienced staff;
• Logistics and Supply Chain – ensuring the efficient distribution of investigational products, handling of biological samples, and managing the overall logistics of the trial across different geographic locations.

During the feasibility process, we also take in mind various factors, such as cultural and ethical specifics, the data privacy and security regulations, the costs, the local standard of health care, potential study and recruitment challenges and more.

Navigating the landscape of clinical trials can be daunting, with unique hurdles to overcome and milestones to achieve. At Comac Medical, we recognize these challenges and stand ready to guide you through every step of the process.

We are experts in delivering tailored and meticulously defined study start-up strategies to each client and our approach is rooted in a deep understanding of study specifications and individual needs, ensuring that every aspect of the process is carefully considered and executed.

We value the collective expertise of our dedicated team comprising feasibility experts, site management specialists, and regulatory affairs managers to transform ambitious timelines into tangible realities.

Our comprehensive study start-up services include:

• Development of customized strategies tailored to specific submissions for each country involved.
• Collaboration and alignment with site representatives to streamline processes and ensure seamless operations.
• Provision of comprehensive documentation and training materials, fostering a thorough understanding of every aspect of the study.
• Direct management of the study submission process, overseeing document gathering, facilitating reviews, and finalizing contracts.
• Ensuring timely initiation of your trial while adhering to the specified budgetary constraints.

We recognize the pivotal role that clinical monitoring plays in the research and development process. With this understanding, we have assembled a team of seasoned professionals who bring a wealth of experience and expertise to every project.

Our commitment is to provide tailored clinical monitoring services that align seamlessly with your study specifications and protocols, ensuring the highest standards of quality and compliance throughout the duration of the trial.

By partnering with Comac Medical for your clinical monitoring needs, you can expect a comprehensive approach that encompasses rigorous site visits, meticulous data review, and proactive risk management strategies. Our team is dedicated to fostering open communication and collaboration with all stakeholders involved, facilitating a smooth and efficient monitoring process from start to finish.

Our clinical monitoring services and responsibilities include:

• Expert support for site identification and selection, including on-site or remote pre-study visits;
• Verification to protect the rights and well-being of clinical study participants;
• Monitoring to confirm safety and data integrity;
• Training of investigational site staff;
• Informed consent/document translation, verification, and back-translation;
• Preparation of regulatory or ethics/review board submissions;
• Timely submission of protocol/consent and other essential documents;
• Warehousing pharmaceuticals, overseeing intellectual property, and managing materials for clinical studies;
• Reporting of protocol digressions;
• Regular, comprehensive reporting to keep you informed.

Our medical monitoring services aim to support the study sites by addressing inquiries related to your study. This may include reporting safety concerns, addressing queries related to patient care coordination, analyzing safety trends and more.

Comac Medical’s medical monitors are qualified professionals, with more than 20 years of experience in managing and monitoring trials across a large range of therapeutic areas. Our team’s primary responsibilities include (but are not limited to):

• Review of relevant patient clinical data;
• Review of medical coding;
• Therapeutic training of operational teams;
• Addressing site, PI, and team medical questions throughout the study;
• Review out-of-range lab values;
• Assessment of significance and reportability;
• Assessment of protocol deviations;
• Medical review of tables/figures/listings;
• Medical review of patient narratives.

Our experienced regulatory affairs team will make sure your health product complies with all legal requirements. We develop tailored regulatory strategies, based on every client’s needs and product specifications to ensure all processes align with the global compliance standards.

With a focus on precise documentation and keeping up-to-date with changing regulations, we will pave the way for your clinical research success.

Our regulatory affairs team full strategic and operational support includes:

• Communication with the ECs and RAs on a regular basis;
• Preparing, reviewing, and submitting regulatory applications;
• Maintenance of regulatory intelligence;
• Development of regulatory strategies.

Our quality assurance team is dedicated to applying the highest standards throughout every phase of your clinical trial. We design and implement quality systems, conduct in-depth audits, and ensure regulatory compliance to guarantee the integrity and reliability of your study data.

With more than two decades experience in the industry we perform audits of internal systems, processes, departments, and all services and procedures related to your study.

Our core quality assurance services include:

• Investigator site audits;
• Quality event management/CAPA;
• Vendor audits;
• System and process audits;
• Regulatory inspection preparation support and management;
• Regulatory GxP training;
• Oversight and management of document control;

We translate complex clinical data into practical insights. From study design to statistical analysis, our clinical biostatistics team will cooperate with your team to guarantee the integrity and reliability of your research results.

The expertise of our biostatistics team covers the full package of statistical consulting solutions and statistical programming required in Phase I-IV trials in various therapeutic areas:

• Study design;
• Data mining methodology;
• PK analysis;
• Development of protocols, incl. sample size and power calculation;
• Randomization and integration with IMP management, IVR and IWR systems;
• Statistical analysis plan creation;
• Statistical analysis and consulting (incl. interpretation of statistical results);
• Interim analysis reports;
• Integrated clinical study report and standalone statistical reports;
• Data integration across studies;
• ADaM datasets preparation;
• SAS® programming, including:
  • Analysis database/ SAS datasets
  • Data tables and listings
  • Graphical data presentation

Our clinical data management team is here to ensure the flawless collection, integration, and availability of your clinical trial data, applying the highest standards of quality at every step. We tailor our clinical data management services to enhance your trials with precision, efficiency, and strict adherence to compliance.

Our comprehensive package of data management services focuses on the management of all aspects from rapid data entry to query resolution and database lock (DBL):

• CRF design (Both paper and EDC);
• Configured solutions;
• EDC system roles management;
• Data cleaning / Query resolution;
• Edit checks programming;
• Medical and listings review;
• Reconciliation of external data;
• Database set-up module (CDASH, SDTM and custom libraries);
• Clinical coding with industry standards and client-specific dictionaries;

Medical communication is a key contributor to the regulatory success of a product. Our team of medical writers consists of specialists with both scientific background and therapeutic knowledge. Our package of medical writing services includes:

• Protocols and protocol amendments (early phase, late phase, and non-interventional studies);
• Informed consent forms and patient information leaflets;
• Clinical study reports (CSRs);
• Subject narratives;
• Investigator brochures (IBs);
• Literature summaries;
• Clinical expert reports;
• Scientific manuscripts:
  • Preparation of SMA
  • Manuscripts
  • Abstracts
  • Posters
  • Meeting publications
  • Slide presentations

With a steadfast commitment to ensuring drug safety and regulatory compliance, Comac Medical offers tailored solutions to support clients throughout the product life cycle.

Combining extensive expertise in pharmacovigilance, risk management, and regulatory affairs, Comac Medical delivers high-quality services backed by advanced technology and innovative methodologies. Our dedication to excellence and continuous improvement enables clients to navigate complex regulatory landscapes with confidence, ultimately advancing patient safety and public health. We provide:

• Clinical trials safety management:
  • Preparation of SMA
  • Full processing of individual cases
  • Periodic reports preparation (line listings, DSUR)
• Post marketing activities:
  • Preparation of SMA
  • Literature search and review
  • Product complaint managements
  • PSMF preparation and maintenance
  • Risk-management, crisis management & consulting (preparation of RMP)
  • Qualified person for pharmacovigilance (QPPV) in Europe
  • Local (PV) contact person
  • Aggregate periodic reporting (PSUR, etc.)
• Safety database hosting with electronic regulatory reporting in EudraVigilance
• Global interaction with and reporting to competent authorities
• Generation of CIOMS reports
• Product reporting within XEVMPD

Comac Medical’s laboratories use state-of-the-art equipment and is GCP compliant. Our labs have responsive teams of experts which work with innovative methods to bring timely, high-quality services.

Laboratory Expertise:

Central Clinical Laboratory:

• Wide range of technologies and applications (hematology, clinical and special chemistry, immunology, microbiology, biomarkers assessments);
• Preparation of laboratory manuals;
• Preparation of laboratory kits and patient forms;
• Sample handling, management and storage;
• Flexible logistics services;
• Shipment monitoring;
• Investigator support;
• Dedicated laboratory project management;
• Data export capabilities (incl. in STDM compliant format).

Bioanalytical Laboratory:

• Regulatory method development and validation (small and large molecules);
• Expertise in different analytical techniques (LBA and LC-MS/MS);
• Expertise in “Fit For Purpose” validation for early phase clinical studies and biomarkers;
• Association with industry advisory groups;
• GCP compliance;
• Lab data transfer (incl. SDTM format);
• Immunogenicity analysis.

A good understanding of how drugs move through the body is crucial for making the right decisions through the whole process during the drug development and clinical trial design.

Pharmacokinetics / Pharmacodynamics (PK/PD) also plays a crucial role in getting drugs approved – about a quarter of the information on a drug’s label comes from PK and PD data. Planning the drug development process carefully and designing studies smartly can speed up the whole process, ensuring you can achieve safety and effectiveness goals.

Comac Medical offers guidance for future studies by optimizing study designs regarding dose selection, population selection, sampling schedule, drug-drug interactions, etc. Our services include:

• PK/PD and PBPK modeling;
• Team consists of clinical pharmacologists and biostatisticians;
• Software used – SimBiology;
• Types of studies:
  • PK in special populations (hepatic and renal impairment, elderly);
  • Drug-drug interaction;
• Experience with EMA and FDA regulations.