Thanks to our local presence and experience, Makolet Pharma has established a unique database of regional sites and centers of excellence, as well as an elite group of research- oriented investigators who can conduct global clinical studies at international standards. Depending on the phase and indication of your study, we select a number of KOLs within key institutions, to grant you the best possible access to patients required for your study.
At Makolet Pharma, we understand the regional epidemiology of our specialized therapeutic areas. Therefore, depending on the disease and the indication, our patient recruitment team designs an efficient plan to maximize your patient-to-site ratio, specifically tailored to your study needs. We offer patient referral models and advertising solutions as part of our recruitment plans, always in accordance with GCP.
Makolet Pharma believes that study start-up not only requires the knowledge of local requirements, but the ability to support both sponsor and investigator in meeting such requirements within the shortest possible timeframes. Thanks to our extensive experience in start-up, Makolet Pharma is well positioned to deliver complete start-up solutions within unprecedented timelines.
Our therapeutic focus stems from the long term experience of our team with various indications in immunology, haematology, oncology and rare diseases. Thanks to this wide ranging experience and excellent communication structures, our monitoring team is able to select and recruit sites that can meet your study milestones at high quality standards. Our team also ensures patient safety during clinical trials and guarantees the validity of your trial data. We take pride in having a team of the most skillful clinical research professionals in the region:
- 5+ years of monitoring experience
- English / Arabic/ French speaking CRAs
- ACRP certified and GCP trained
Our project management team offers relevant expertise to your specific project needs, including both observational and interventional studies. Our strategy is to understand all project details from the very beginning, so that we can be prepared for any specific project requirements. For each project, our team will prepare a project plan and a detailed risk assessment plan. We offer the flexibility of working as per our internal SOPs, or as per Sponsor SOPs. We also have the ability to offer staffing of experienced, full time project managers.
Makolet Pharma offers high quality content for your clinical trial documents. From protocol to manuscript, our specialized medical writers have a track record in producing clinical trial documents at international standards. Their medical background and understanding of the disease area, together with years of writing experience, translates into proven efficiency that our clients recognize and value. We work with both Sponsors and investigators, to design study protocols consent forms, and case report forms. We also produce clinical study reports and manuscripts for publication in regional and international journals.
Quality is an integral part of the clinical research industry in general, and a key value for Makolet Pharma in particular. In addition to our own internal commitment to quality, our quality experts are also available to offer you the following support:
- Trial Master File Audits
- Investigator Site Audits
- Vendor Audits
- Trial Master File Audits
- Phase I Facility Audits
- Clinical Study Report Audits
- Laboratory Audits
- GMP/GCP Audits of Clinical Trial Supply Providers