Our Services

S.W.O.T. Project and Program Managers are well-versed in planning and overseeing the entire product development process, from discovery through clinical trials to regulatory approval and thereafter including corporate meeting planning. Our project manager will use the best program management tools to ensure your asset development projects and milestones are well-defined, have clear objectives, and adhere to strict timelines and budgets. The team is personable and professionally trained to get the best out of each contributing team members.  We meet your team where they are and will ensure they are set up for success. 

With end-to-end support in mind, from preclinical to late-stage, commercialization and global alignment of submissions and dossiers,  S.W.O.T. Regulatory Operations Consultants are experienced with projects that involve:

• Managing, preparing, and submitting regulatory submissions and dossiers to global health authorities. 

• Consulting and strategizing submissions that are personalized and innovative with the company’s goals in mind.

• Providing regulatory management support by serving as an integrated representation to Sponsor teams.

• Owning the product life cycle with the use of high-quality and region-specific regulatory submission support using validated document management systems for document review and approval, eCTD publishing and archiving.

S.W.O.T. Clinical Operations teams will implement projects to oversee your clinical study operations as contracted with Contract Research Organizations by:

• Coordinating with team members by planning, implementing, managing, executing and overseeing the completion of clinical studies according to applicable regulations and guidance, ICH and GCP, and SOPs, timelines, and budget on behalf of the Sponsor.

• Helping to select the CRO and clinical sites.

• Being responsible for effective communication across internal and external team members.

• Managing and/or oversee the development process for critical study documents (e.g., protocol, amendments, IB, ICF, CRFs and CSRs in support of the regulatory submission.

• Working closely with members of other functional areas to provide input on study-related documents and issues.

While clinical quality assurance is generally the last thing on a new  innovator's mind, it should actually be the first. With a sound quality plan leading the way, the clinical and regulatory pathway to product development will lead to fewer surprises and potentially costly pitfalls. The S.W.O.T. quality project specialists are knowledgeable and personable alliances who will be there to ensure you are keeping patients safe, abiding by all applicable compliance measures and abide by all regional regulatory agencies' expectations are met. 

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Quality Management and Clinical Quality Assurance team members will assist  with. projects involving:

• Governance document 
  development. ie Policies, SOPs and Work Instructions.

• Quality systems management and training.

• Corrective action planning and response.

• Quality Management Plan development.

• Clinical quality and trial master file audits.

• Inspection readiness.

• Regulatory agency inspection support.

Give your sales team the best systems and processes to reach their goals. Our commercial operations strategists will design and implement projects that includes a sales solution and the implementation of processes to support your sales initiatives. Commercial operations projects include:

• Designing and implementing a CRM plan and solution.

• Creating creating and providing sales management with sales-related reports and documents.

• Assisting with providing input and leadership on commercial strategy, sales compensation and sales analytics.

• Assisting with the quota setting process, compensation design and awards programs that drive sales to meet corporate objectives

• Overseeing sales commission administration.

• Developing and implement new processes relevant to the commercial organization.