Life Sciences Capabilities

We understand the speed in which you need to move and have the right professionals you need whether you work with us through a staffing, project based, or a functional service provider approach. We work with you to determine the specific qualifications and provide the talented professionals that put you on the road to market without losing control.

Capabilities Include:

SOP Revision, click here

We assist mid-size pharmaceutical companies move from a paper environment to EDC. You may be scaling your clinical trials and the volume may require you to change both workflow and process for clinical trials. Before you send work outside of the building, you need to standardize the process for efficiency and compliance issues.

Our team meets with your Data Management team and provides:

  1. Gap analysis

  2. Team member interviews for continuity and process mapping

  3. Draft SOP and work instructions

  4. Review with sponsor team and training

  5. New SOP integration into the system

 
SAS Programming, click here

Working with pharmaceutical companies, we are able to provide SAS programming expertise. We support you with staff as needed and look to build trust in order to show you the difference between our approaches of partnering versus that of being a vendor. We are able to assist with mapping of data, training as well as best practices.

Our team:

  1. Staffs a variety of clinical trials across various phases

  2. Creates an environment of sharing resources for various time sensitive efforts

  3. Provides domain experts in various aspects of the work (Programming, mapping, and report/documentation)

  4. Becomes a flexible extension - a “true partner” of the company.

  5. Scales in both directions (ramping up and winding down to re-allocate) related to the volume of work

 
Data Management Functional Provider, click here

We are able to provide data management services to help with customized requests for support. With a solution that builds consistency and maintains costs for short- and long-term trials, we build your needed team and provide a lead as a main point of contact.

Our team:

  1. Scopes the volume and lead time for the work as well as specific requests with the client

  2. Identifies the lead and assemble the team around the lead

  3. Builds the team, houses the resources, trains the group and connects the teams virtually allowing clients to be more strategic vs tactical

CQV Consulting Team, click here

We provide a commissioning team including commissioning and qualification engineers, user operation and site engineers and document controllers. We serve as a subject matter expert / mentor for the team focused on relevant building equipment such as HVAC, clean utilities, and/or process vessels. Our lead attends coordination meetings and provides weekly status reports and input to the project schedule.

Our team:

  1. Develops protocols to follow the VPP and CP to include start-up, set-up, installation, and verification testing.

  2. Builds the team around our mutually agreed upon subject matter expert

  3. Tracks progress and reviews test reports prior to approval to insure a timely and value add conclusion

 
CAPA / Deviation SME, click here

Develop, write, and review deviation Investigation reports. Propose and initiate CAPAs to eliminate the root cause of potential nonconformities or problems in order to prevent recurrence. Proof-read Deviation Investigation Reports for content, grammar, punctuation, and format consistency. Track and monitor status of deviations assigned, ensuring completion within defined time frames.

Our expert will:

  1. Update existing SOPs (including equipment and maintenance records and drawings), CAPAs, forms, and other types of technical documentation

  2. Document and report progress, status and issues to management on open deviations

  3. Monitor and follow up on pending action items to close deviations

 




Locating the Life Sciences professionals you need does not begin for us when we start speaking with you. We have been forging relationships with professionals on an ongoing basis and are working toward their career development. Our practice is built on the concept that you need fast results and need self-sufficient intelligent professionals and solutions that have been time tested. Others say these things and sadly, you know they don’t mean it. We are determined to prove different. Let us show you the Softworld difference. Judge us, and judge everyone else.
 

Are you going to be strategic spending your time doing your job or tactical spending hours in the hiring process?

Life Science Consulting


Let us show the Softworld difference!