Life Sciences

Where do you find quality data management?

SOP’s …..Are you following or chasing the work instructions?

How do you handle insourcing versus outsourcing?

Is our plan for CAPA ......quantitative or anecdotal?

TLFs, TLGs, Data Sets – Does your output match your expectations?

 

We hear from clients every day that once they complete the pre-clinical phase, they have difficulty locating and attracting the skilled professionals they need to move forward. They can’t move quickly causing time delays against the ever clicking market clock of their proprietary patent.

Additionally, each sponsor has their own views of the right approach for bringing in consultants or outsourcing. The question for these sponsors starts with access to a deep pool of professionals with the skills that fit their needs or turning it over to an outside firm and potentially losing control.

Softworld Life Sciences provides the needed expertise and experts to help pharma, biotech, and medical device companies bring products to market in a safe, compliant and timely manner. 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. Our professional services group, Vita Data Sciences, provides unparalleled services in clinical data analytica and functional outsourcing biometrics. 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.

We provide talented professionals and solutions across these practices area:

Biometrics, click here
  • Biostatistics

  • SDTM / ADaM

  • CDISC/CDASH Analyst
  • SAS Programming

  • Data Mapping

 
Clinical, click here
  • Clinical Data Management

  • CDR

  • Clinical Project Management

  • EDC and Study Build

  • Medical Coding

  • Clinical Operations

 
GCP, GMP, GLP, GXP, click here
  • Metrics

  • QMS

  • Best Practices

  • Audit / Mock - Prep

  • Process Improvement
  • 21 CFR Part 11
Validation, click here
  • Process

  • Cleaning

  • Aseptic
  • Equipment Packaging

  • Protocol Writing

  • CQV / FAT

  • CSV

  • Commission / Decommission

  • Metrology

 
Regulatory, click here
  • Submission Management

  • IND / NDA

  • Dossier Compilation
  • Compliance Remediation

  • Regulatory Strategy

  • Post approval maintenance

 
Quality, click here
  • CAPA / Root Cause

  • 483 / Consent

  • Deviation

  • Process Improvement

  • SOP / Documentation

  • Batch / Deviation Review

  • Protocol Writing

 
 

 

Delivery Models Include:

Staffing We provide you the talented individuals or teams of people within Biostats, Clinical and GCP.
Project Let us help scope the project with you and build the team to deliver on-time and on-budget.
Functional Service Provider        We work with you, understanding your needs, in order to build a functional team (people, processes and systems) that reduces physical infrastructure and drives effective and efficient outcomes.

 

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!