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    Pharma Services Category of Factory CRO

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    HTL Biotechnology is the world leader in the responsible development and production of pharmaceutical-grade biopolymers.
    Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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    01 Compliance, Regulatory & Consulting (6)

    02 Medical Writing & Language Translation (1)

    03 Patient / Investigator Recruitment (1)

    04 Post Marketing (2)

    05 Technology / Data / Analytics (2)

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    01 Factory CRO (12)

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    Factory CRO

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      CLINICAL EVALUATION REPORT (CER)

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      Factory has an expert team of medical writers that has this knowledge and experience and that can help you compiling these reports making sure you do it right the first time so you don’t loose time and resources.

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      Pharma Service: Clinical Trials

      Category: Medical Writing & Language Translation

      Sub Category: Clinical Research Translation / Validation
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        POSTMARKETING SURVEILLANCE (PMS)

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        Factory has expertise in the design, conduct, analysis and reporting of PMS studies. Results from well-designed PMS studies can strengthen your marketing and sales efforts.

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        Pharma Service: Clinical Trials

        Category: Post Marketing

        Sub Category: Pharmacovigilance / Product Lifecycle Management
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          CE MARKING

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          We are well acquainted with CE-marking studies and can assure that your study can be designed and controlled to meet the demands of Notified Bodies.

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          Pharma Service: Clinical Trials

          Category: Compliance, Regulatory & Consulting

          Sub Category: Quality & Compliance
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            SAE / AE REPORTING

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            Our MDs are experts in the safety evaluation and handling of Serious Adverse Events that are reported during the trial follow up period.

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            Pharma Service: Clinical Trials

            Category: Post Marketing

            Sub Category: Pharmacovigilance / Product Lifecycle Management
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              CLINICAL MONITORING

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              One of the services that distinguish us from conventional CROs is our clinical monitoring service. We are proud to have experienced technical experts in different clinical fields who can provide monitoring of clinical procedures so that you can verify that your device is used as you intended.

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              Pharma Service: Clinical Trials

              Category: Technology / Data / Analytics

              Sub Category: Clinical Trial Monitoring
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                INTERNATIONAL CLINICAL TRIAL RESCUE

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                We are proud to offer our early-detection program designed to help medical device companies correct poorly designed clinical trials, effectively saving the study from ultimately being rejected by FDA or European regulators.

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                Pharma Service: Clinical Trials

                Category: Compliance, Regulatory & Consulting

                Sub Category: Quality & Compliance
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                  PATIENT INCLUSION & 24 HOURS RANDOMIZATION

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                  We are counted on for swift and reliable clinical medicalndevice/IVD services by companies and clients from everyncorner of the globe.

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                  Pharma Service: Clinical Trials

                  Category: Patient / Investigator Recruitment

                  Sub Category: Patient Recruitment
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                    PROTOCOL / STUDY DESIGN

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                    Our extensive experience and knowledge can help you plan a optimal study design. In addition to our internal expertise, you can get direct market feedback through meetings with panels of clinical experts. Let us be your bridge to the key opinion leaders and surgical experts throughout Europe.

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                    Pharma Service: Clinical Trials

                    Category: Compliance, Regulatory & Consulting

                    Sub Category: Clinical Trial Design
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                      FDA REGULATORY STRATEGY

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                      Factory’s team has a broad and in depth knowledge on FDA requirements and procedures and can help you design a regulatory strategy specific for your device.

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                      Pharma Service: Clinical Trials

                      Category: Compliance, Regulatory & Consulting

                      Sub Category: Quality & Compliance
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                        TIMELINES & BUDGETARY CONTROL

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                        Controlling development timelines and budgets are essential for companies that want to bring a medical device to the market. Factory’s control systems give you all the information you need to keep you informed and stay in control of the process, every step of the way.

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                        Pharma Service: Clinical Trials

                        Category: Compliance, Regulatory & Consulting

                        Sub Category: Consulting Services
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                          EUROPEAN REGULATORY STRATEGY

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                          We would be happy to provide a free consultation about your European regulatory strategy, without any future obligation. We can assist with Notified Body selection and negotiations.

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                          Pharma Service: Clinical Trials

                          Category: Compliance, Regulatory & Consulting

                          Sub Category: Quality & Compliance
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                            DATA MANAGEMENT

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                            Our data-managers are part of the team to make a medical device study a success. They actively participate in the design and implementation of a trial, using their vast experience and specific medical device knowledge to serve the goal of the study.

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                            Pharma Service: Clinical Trials

                            Category: Technology / Data / Analytics

                            Sub Category: Data Management
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