What we do

Clinical Development - We provide help and input in developing your clinical development plan..

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• Drafting or review of a clinical development plan to support region-specific or global developments for your drug or device.

• Protocol development including study design, clinical endpoints, and inclusion/exclusion criteria.

• Feasibility assessments

• Help with documents such as the Protocol, informed consent form (ICF), safety management plan (SMP), etc.

• Help deciding on whether you should focus on a Country, a  region or Globally to undertake a study based upon key selection criteria.

• Should it be a validation or first-in-human (FIH) study?

• Any aspect of Phase I-IV studies

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Any of the above studies can be performed in any part or region of the world. Typically, a few companies prefer to perform validation or FIH studies in countries outside the United States to reduce costs and validate the drug or the medical device.

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Site identification, recruitment and management - We realize how difficult it is to conduct clinical studies for sponsors and for CROs. It has become even more difficult since the pandemic. Recruiting patients and retaining them are a constant issue. We work with you to help identify and recruit high-recruiting sites who have experience in the indication of your choice. We have established relationships with sites around the country and the world, and we will work closely with you before and during the clinical study to make sure your targets are met, and the budget does not run overboard. 

Regulatory Support - We have experts in regulatory strategy, who can work with you and help develop a strategy that minimizes risks and increases clinical trial success. We also work with you help respond to data requests or other information requests from agencies in regulatory matters; helping prepare documents; strategizing; and helping prepare filings in regulatory proceedings.

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Statistical help - We can support your statistical needs with input from our statistical experts who can help you with the design of the clinical study, the regulatory needs and clinical study data analysis.  

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Preclinical studies - Do let us know if you require support in planning or implementation of a preclinical study. Our staff can help you connect with CROs, design the study, and help monitor.

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Medical Affairs - 

We can support your MedAffairs requirements in terms of publications, abstracts, conference submissions, journal articles, etc. as well as planning steps in areas of medical liaison.  

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Clinical Operations - If you need help with reaching out to CROs, discussions and budgeting for clinical operations, planning studies from ClinOps perspective, please let us know. 

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Commercialization & Marketing - These areas require specific inputs and steps to plan for the launch of your drug or device. Apart from regulations, you have to consider forming a sales team in the country or region of the world, or globally. Aspects such as logo, packaging inserts, packaging design, etc. play an important part.

 

Due Diligence - If you are a Venture firm or an investor, and require someone to review a potential investment company or opportunity, please reach out. We have experience in due diligence that led to multimillion investment.