KNOWLEDGE AND EXPERTISE @ WORK FOR YOU.. TO DELIVER YOUR PRODUCTS ON TIME AND WITHIN BUDGETS…
DEPENDABLE QUALITY, TIMELINESS, RESPONSIVENESS AND RELIABILITY
At Optimus, our team of knowledgeable clinical development writing professionals offer expert consulting and provide optimal solutions starting from discovery through commercialization. We design and implement drug development writing projects specifically tailored to your organisation and or product/s.
We use a blend of proven operational methodologies, processes, Standard operating procedures (SOP’s), technology, infrastructure, tools, templates and the ‘right’ kind of human intellect to deliver our projects consistently on time and agreed upon quality guidelines to generate significant ROI. Optimus offers the following services in this area…..
|CLINICAL OPERATIONS||CLINICAL DATA MANAGEMENT||REGULATORY||CLINICAL STUDY|
|Standard Operating Procedures (SOP’s)||Case Report Form (CRF) design||Periodic Safety Update Reports||Protocols|
|Study/ Trial documents||GCDMP documents & SOP’s||Drug & Site master files||Informed Consent development|
|Trial management plans & Checklists||Validation documents||SOP’s||Investigators Brochure development|
|All regulatory submissions|
We manage, develop and implement distinctive and compelling implementation strategies to deliver effective projects by working hand in hand with operational teams and organisations involved in drug discovery and development.
Our services can begin early in development by creating organisation / study / function specific SOP’s, continue through writing therapeutic, phase and study specific protocols and authoring reports. Post-marketing writing services include PSUR writing, regulatory report writing, country specific export / import regulatory dossier preparation.
The team at Optimus is flexible to fit your needs. We can provide selected or comprehensive services either from our facility or onsite at your facility as required to meet your specific program needs.