Services Offered to Companies Without Research Staff in North-America Attention: EUROPEAN, JAPANESE, & AUSTRALIAN PHARMACEUTICAL COMPANIES With more than 16 years experience as a partner in clinical research, SciAn has the expertise and breadth of experience to help you carry out your North-American clinical research program quickly and cost-effectively. We can assist you in the regulatory approval of your clinical program, manage your clinical studies and submit your application to FDA and TPD. |
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Protocol
Development Our senior consultants will collaborate with you in the design of clinical studies required for the North-American regulatory and healthcare environment. Regulatory: INDs We will prepare (pre-)IND packages, organize and attend meetings with FDA and TPD. Trial Setup & Management We will plan, initiate and manage your studies. Our experienced staff is able to independently manage the projects or carry out each task in collaboration with your staff or other CROs. Data Management Our expert Clinical Data Management group will perform data entry on an ongoing basis as per all regulatory guidelines and standards. Biostatistics & Reporting Integrated research reports will be prepared as per ICH guidelines and your SOPs for incorporation into your NDA. We are equipped to handle all Serious Adverse Event reporting on your behalf. Regulatory: NDAs We will prepare the clinical segment of your NDA for filing to FDA and TPD. Project Management Independent of geographic location, we will provide your team with up-to-date and reliable information on the status of your studies using our state-of the-art information management system. |
View our services in more detail. View how our services comply with all regulatory guidelines. We look forward to collaborating with you in the near future, please contact us. |
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