Knowing what we don’t know is in our opinion the better way than claiming we know everything, and the basis of how we offer our support. We provide consulting services based on our experience and expertise, because we are committed to work with our clients to find the best solutions. This is our commitment to you, and the many clients that have come back to us repeatedly for such services over the years.
CLINICAL DEVELOPMENT PLAN
Long-standing experience in the design of CDPs and protocols to match regulatory requirements while ensuring medical and operational soundness.
Our medical, biostatistical, regulatory and operational experts have a long standing record on consulting our clients on program and protocol design, clinical development plans, PIPs and other aspects. We focus especially on our core areas of expertise: Oncology, Immunology, Respiratory & Allergy, Endocrinology, and GI.
MEDICAL AND SCIENTIFIC CONSULTING
Independendent data monitoring boards during your trial managed by our experts.
Our clinical research physicians have substantial experience in the conduct of data safety monitoring boards, blinded reviews and dose-escalation designs, in particular in oncology. Together with our biostatisticians and supported by a strong clinical data management function, and our pharmacovigilance staff as needed, we are able to provide full and independent solutions for blind data reviews and any kind of data monitoring committees. We offer this as an independent organization where the blinding of your currently used CRO and your team needs to be ensured, or as part of our own full service studies, with appropriate segregation of responsibilities. We commonly work closely with investigators and opinion leaders as well as Sponsor staff in these committees.
Support in setting up and maintaining a quality management system for the conduct of clinical trials (GCP).
Our QA team is highly experienced to provide flexible and client-specific QA consultancy ranging from selected aspects of a quality management system up to the setup or review of an entire system in the GCP area. For example:
- Writing client-specific SOPs and working instructions.
- Developing forms exactly for your needs.
- Review and revision of existing SOPs.
- Gap analysis of a QMS.
Based on our practical experience with inspections by authorities, we can support our clients during the preparation or follow up of authority inspections. If required our QA experts can develop action plans and guide the client through the CAPA process.
A European GCP Training & Compliance Department providing a program of extensive training to Clinical Investigators, Study Teams and Sponsors, tailored to their individual needs.
Our training programs are based on nearly 20 years of comprehensive experience. One or two day full time ICH GCP basic- / refresher trainings for Investigators and Study Teams (certified by the State Medical Associations in Germany), practical one day Study Team Workshops, training on specific drug development aspects such as Clinical Monitoring, Pharmacovigilance & Safety reporting, Time Management, etc. for Clinical Operations staff, Train the Trainer programs and also Accompanied Training and Compliance Visits (QC measure) are our main offers.
A team of operational and medical experts to conduct global feasibility to ensure trial success.
Having conducted hundreds of studies, we can perform feasibility studies from a medical, regulatory and operational perspective. This is based on a dedicated process consisting of the operational and regulatory insight in the countries we operate. Combined with medical and operational considerations, data show that studies run by Linical complete early and on time, compared to industry averages, which validates our approach.