Regulatory

FDA, along with other regulatory bodies, requires independent oversight of safety, post-market surveillance, patient outcomes, and medical education. At KamGen consulting, we provide independent Data Monitoring Committees (DMC), and Central IRB services.

We keep biotechnology, pharmaceutical, and medical devices companies in compliance with regulatory requirements, which are of crucial in the current ever-changing regulatory environment.

Our DMC team of experts, most notably our oncology/hematology clinicians and biostatisticians, independently evaluate interim clinical data in order to make recommendations for the continuation, alteration or possible termination of a given clinical trial.  The fact that our independent DMC team members are specialized in hematology and oncology, and are extremely competent in such areas as lymphoma and solid tumors,  would provide an extremely quick fast turnaround for these projects, enabling sponsors to save valuable time and resources on trials that are in need of modification, or redesigning of the trial protocol.

At KamGen Consulting, we support most independent monitoring committees, such as independent DMC, clinical events committee (CEC), Clinical trial steering committee, and adjudication panels, to ensure complete compliance with FDA guidelines, and to help sponsors ascertain the safety and efficacy of their products for patients

Regulatory Guidance:

We provide independent central Data and Safety Monitoring Board (DSMB) to our clients in biotechnology, pharmaceutical, and medical devices companies, in accordance with the FDA guidelines. Since KamGen Consulting is not a Clinical Research Organization (CRO), or a Data Management Center, you will receive a complete independent and unbiased assessment of the patient safety and treatment efficacy data.

For years we have provided many oncology DMCs to our clients, several of which benefited lymphoma trials. We have exclusive hemato-oncologists as well as bio-statisticians on board to independently review the available data. Our independent DMC will rapidly provide information in moving forward with orphane, as well as typical large-scale trials.

Allow us to save you millions of dollars in possible damages, and loss of valuable time.

Central IRB services:

Patients’ safety and welfare are our most urgent concerns. By providing central IRB services to our clients (sponsors, CROs, researchers and institutions), we ensure the expedited IRB reviews of multi-center clinical research projects. We strive to enhance our services continuously in order to best support scientifically sound, and ethically valid clinical research programs, as well as meeting and exceeding the regulatory requirements of clinical projects, at all levels.