Project Management group works on keeping each project on time and within planned budget.
Each Project Team is motivated and integrated, with local expertise and therapeutic experience and knowledge.
We are providing personalized service that meets the needs of customers of all sizes for projects of every scope.
Our project management team works closely with the scientific team to ensure the smooth progression of your clinical trial.
Our Project Managers work effectively and diligently to manage all critical aspects of the study to ensure on-time delivery of results, within budget and with the highest possible quality output.
Our team will work with you on every aspect of the trial from the first regulatory submissions through to closeout and final reporting to help you and guide your project to succeed.
- Phase I-IV protocol development
- Clinical study reports according to ICH E3 and eCTD format
- Translations of regulatory documents
- Investigator’s brochure development
- SOP development
- Informed Consent Form including local language ICFs
- Our team has the knowledge to support your needs throughout the product lifecycle. This includes defining the regulatory development strategy, producing clinical trial and marketing authorization submissions, etc.
Our experienced team not only helps you create your strategic clinical development plan, but also provides tactical support to develop the clinical trial design; determines sample size calculations; writes, edits or reviews protocols and so on.
Our team will guide you in planning targets and develop strategies to help you in reaching them.
We use an out-of-the-box thinking approach to produce creative solutions that will help you meet your development goals faster.
Each project is unique and has its own set of challenges and complexities related to its design or regulatory strategies. Our team will be there to identify possible pitfalls and proactively solve them, resulting in time and cost benefits for you.
Having experience with recruiting for many studies across therapeutic areas we know what geographical locations may work better for recruitment . Choosing the right locations for your studies, this simple action can be the deciding factor between success & failure.
With years of successful clinical research submissions to regulatory agencies, our team of consultants has a specialized skill of clear and precise writing. We are able to assist you with protocol writing, study reports, IB and other essential documents.